Annexes - État des connaissances - Innocuité de la substitution et de l'interchangeabilité des médicaments biologiques

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Innocuité de la substitution et de

l’interchangeabilité des médicaments biologiques

Annexes complémentaires

ÉTAT DES CONNAISSANCES

MAI 2020

Une production de l ’Institut national d’excellence en santé

et en services sociaux (INESSS)

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Innocuité de la substitution et de

l’interchangeabilité des médicaments biologiques

Annexes complémentaires

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Le présent document contient les annexes complémentaires au rapport Innocuité de la substitution et de l’interchangeabilité des médicaments biologiques.

Le contenu de cette publication a été rédigé et édité par l’INESSS.

Ces annexes et le rapport final sont accessibles en ligne dans la section Publications de notre site Web.

Renseignements

Institut national d’excellence en santé et en services sociaux (INESSS) 2535, boulevard Laurier, 5e étage

Québec (Québec) G1V 4M3 Téléphone : 418 643-1339 Télécopieur : 418 646-8349

2021, avenue Union, bureau 10.083 Montréal (Québec) H3A 2S9

Téléphone : 514 873-2563 Télécopieur : 514 873-1369

inesss@inesss.qc.ca www.inesss.qc.ca

Responsabilité

L’Institut rend accessibles les principales informations qui ont servi à l’état des

connaissances sur les Stratégies de cessation tabagique aux lecteurs qui désirent plus de détails sur sa démarche scientifique.

Ce document n’a pas fait l’objet d’une révision linguistique. Il ne reflète pas forcément les

opinions des autres personnes consultées aux fins du présent dossier.

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TABLE DES MATIÈRES

ANNEXE A ... 1

Stratégies de repérage de l’information scientifique ... 1

ANNEXE B ... 3

Sélection des documents et listes et raisons des exclusions ... 3

ANNEXE C ... 18

Évaluation de la qualité méthodologique des documents ... 18

ANNEXE D ... 35

Caractéristiques des études primaires retenues ... 35

ANNEXE E ... 169

Tableaux de résultats ... 169

ANNEXE F ... 270

Appréciation de la preuve scientifique ... 270

REFERENCES ... 290

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LISTE DES TABLEAUX

Tableau B1 – Liste des documents exclus ... 4

Tableau B2 – Liste des documents inclus ... 6

Tableau C1 – Évaluation des études primaire : Grille ASPC ... 18

Tableau C1 – Évaluation des études primaire : Grille ASPC (suite 1) ... 19

Tableau C1 – Évaluation des études primaire : Grille ASPC (suite 2) ... 20

Tableau C1 – Évaluation des études primaire : Grille ASPC (suite 3) ... 21

Tableau C1 – Évaluation des études primaire : Grille ASPC (suite 4) ... 22

Tableau C1 – Évaluation des études primaire : Grille ASPC (suite 5) ... 23

Tableau C1 – Évaluation des études primaire : Grille ASPC (suite 6) ... 24

Tableau C1 – Évaluation des études primaire : Grille ASPC (suite 7) ... 25

Tableau C2 – Évaluation des guides de pratique clinique retenus (AGREE-GRS) ... 26

Tableau C3 – Résumé de l’évaluation AACODS pour les énoncés de position retenus ... 27

Tableau C3 – Résumé de l’évaluation AACODS pour les énoncés de position retenus (suite 1) ... 29

Tableau C3 – Résumé de l’évaluation AACODS pour les énoncés de position retenus (suite 2) ... 31

Tableau C3 – Résumé de l’évaluation AACODS pour les énoncés de position retenus (suite 3) ... 33

Tableau D1 – Caractéristiques de Abdalla 2017 ... 35

Tableau D2 – Caractéristiques de Alten 2019 ... 36

Tableau D3 – Caractéristiques de Argüelles-Arias 2017 ... 38

Tableau D4 – Caractéristiques de Avouac 2018 ... 40

Tableau D5 – Caractéristiques de Belleudi 2019 ... 41

Tableau D6 – Caractéristiques de Benucci 2017 ... 43

Tableau D7 – Caractéristiques de Bergqvist 2018 ... 44

Tableau D8 – Caractéristiques de Blackwell 2018 ... 46

Tableau D9 – Caractéristiques de Blauvelt 2018 ... 48

Tableau D10 – Caractéristiques de Blevins 2019... 50

Tableau D11 – Caractéristiques de Bonifati 2019 ... 52

Tableau D12 – Caractéristiques de Bronswijk 2020 ... 54

Tableau D13 – Caractéristiques de Buer 2017 ... 55

Tableau D14 – Caractéristiques de Cohen 2020... 57

Tableau D15 – Caractéristiques de Cohen 2018... 59

Tableau D16 – Caractéristiques de Eberl 2017 ... 62

Tableau D17 – Caractéristiques de Emery 2017 ... 63

Tableau D18 – Caractéristiques de Fabiani 2019 ... 65

Tableau D19 – Caractéristiques de Felis-Giemza 2019 ... 66

Tableau D20 – Caractéristiques de Fiorino 2018 ... 68

Tableau D21 – Caractéristiques de Genovese 2019 ... 69

Tableau D22 – Caractéristiques de Gervais 2018 ... 71

Tableau D23 – Caractéristiques de Glintborg 2019... 73

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Tableau D24 – Caractéristiques de Glintborg 2017... 74

Tableau D25 – Caractéristiques de Goll 2019 ... 76

Tableau D26 – Caractéristiques de Griffiths 2017 ... 78

Tableau D27 – Caractéristiques de Guerra Veloz 2019 ... 81

Tableau D28 – Caractéristiques de Guerra Veloz (REED) 2018 ... 83

Tableau D29 – Caractéristiques de Guerra Veloz 2018 (WJG) ... 84

Tableau D30 – Caractéristiques de Guerrero Puente 2017 ... 86

Tableau D31 – Caractéristiques de Guiotto 2019... 87

Tableau D32 – Caractéristiques de Haag-Weber 2009 ... 89

Tableau D33 – Caractéristiques de Hadjiyianni 2016 ... 90

Tableau D34 – Caractéristiques de Hercogova 2020 ... 92

Tableau D35 – Caractéristiques de Hoivik 2018 ... 94

Tableau D36 – Caractéristiques de Jaworski 2019 ... 95

Tableau D37 – Caractéristiques de Jorgensen 2017 ... 98

Tableau D38 – Caractéristiques de Kaltsonoudis 2019 ... 101

Tableau D39 – Caractéristiques de Kang 2018 ... 102

Tableau D40 – Caractéristiques de Kolar 2017 ... 103

Tableau D41 – Caractéristiques de Lukas 2020... 105

Tableau D42 – Caractéristiques de Matsuno 2019 ... 106

Tableau D43 – Caractéristiques de Minutolo 2017... 108

Tableau D44 – Caractéristiques de Nikiphorou 2015 ... 109

Tableau D45 – Caractéristiques de Papp 2017 ... 111

Tableau D46 – Caractéristiques de Park 2017 (CT-P10) ... 113

Tableau D47 – Caractéristiques de Park 2017 (CT-P13) ... 115

Tableau D48 – Caractéristiques de Pescitelli 2019 ... 117

Tableau D49 – Caractéristiques de Petitdidier 2019 ... 118

Tableau D50 – Caractéristiques de Plevris 2019 ... 120

Tableau D51 – Caractéristiques de Ratnakumaran 2018 ... 121

Tableau D52 – Caractéristiques de Razanskaite 2017 ... 122

Tableau D53 – Caractéristiques de Rosenstock 2015 ... 123

Tableau D54 – Caractéristiques de Scherlinger 2018 ... 126

Tableau D55 – Caractéristiques de Schmitz (APT) 2017 ... 127

Tableau D56 – Caractéristiques de Schmitz 2018 ... 128

Tableau D57 – Caractéristiques de Shim 2019 ... 129

Tableau D58 – Caractéristiques de Sieczkowska 2016 ... 131

Tableau D59 – Caractéristiques de Smits 2019 ... 132

Tableau D60 – Caractéristiques de Smits 2017 ... 134

Tableau D61 – Caractéristiques de Smits 2016 ... 135

Tableau D62 – Caractéristiques de Smolen 2018 ... 136

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Tableau D63 – Caractéristiques de Strik 2018 ... 138

Tableau D64 – Caractéristiques de Tanaka 2016 ... 140

Tableau D65 – Caractéristiques de Thadhani 2018 ... 143

Tableau D66 – Caractéristiques de Tony 2019 ... 146

Tableau D67 – Caractéristiques de Tweehuysen 2018a ... 148

Tableau D68 – Caractéristiques de Tweehuysen 2018b ... 150

Tableau D69 – Caractéristiques de Van Hoeve 2019 ... 152

Tableau D70 – Caractéristiques de Vergara-Dangond 2017 ... 153

Tableau D71 – Caractéristiques de Von Minckwitz 2018 ... 155

Tableau D72 – Caractéristiques de Weinblatt 2018 ... 157

Tableau D73 – Caractéristiques de Yamanaka 2020 ... 159

Tableau D74 – Caractéristiques de Yazici 2018... 161

Tableau D75 – Caractéristiques de Ye 2019 ... 163

Tableau D76 – Caractéristiques de Yoo 2017 ... 167

Tableau E1 – Perte d’efficacité – Maladie de Crohn ... 169

Tableau E2 – Perte d’efficacité – Colite Ulcéreuse ... 172

Tableau E3 – Perte d’efficacité – Maladie inflammatoire de l’intestin (MC, CU, MII non classée) ... 174

Tableau E4 – Immunogénicité – Maladie de Crohn ... 177

Tableau E5 – Immunogénicité – Maladie inflammatoire de l’intestin (MC, CU, MII non classée) ... 178

Tableau E6 – Effets indésirables – Maladie de Crohn ……….… 179

Tableau E7 – Effets indésirables – Colite ulcéreuse ... 181

Tableau E8 – Effets indésirables – Maladie inflammatoire de l’intestin (MC, CU, MII non classée) ... 182

Tableau E9 – Rétention – Maladie de Crohn ... 184

Tableau E10 – Rétention – Colite ulcéreuse ... 186

Tableau E11 – Rétention – Maladie inflammatoire de l’intestin (MC, CU) ... 187

Tableau E12 – Perte d’efficacité – Polyarthrite rhumatoïde ... 188

Tableau E13 – Perte d’efficacité – Spondylarthrite ankylosante ... 192

Tableau E14 – Perte d’efficacité – Arthrite psoriasique ... 195

Tableau E15 – Perte d’efficacité – Arthrite inflammatoire (PR, SA, AP) ... 196

Tableau E16 – Immunogénicité – Polyarthrite rhumatoïde ... 198

Tableau E17 – Innocuité – Polyarthrite rhumatoïde ... 203

Tableau E18 – Innocuité – Spondylarthrite ankylosante ... 209

Tableau E19 – Innocuité – Arthrite inflammatoire (PR, SA, AP) ... 210

Tableau E20 – Rétention – Polyarthrite rhumatoïde ... 212

Tableau E21 – Rétention – Spondylarthrite ankylosante ... 217

Tableau E22 – Rétention – Arthrite psoriasique ... 218

Tableau E23 – Rétention – Arthrite inflammatoire (PR, SA, AP) ... 219

Tableau E24 – Perte d’efficacité – Psoriasis en plaque ... 222

Tableau E25 – Immunogénicité – Psoriasis en plaque ... 225

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Tableau E26 – Innocuité – Psoriasis en plaque ... 229

Tableau E27 – Rétention – Psoriasis en plaque... 235

Tableau E28 – Immunogénicité – Spécialités combinées ... 239

Tableau E29 – Innocuité – Spécialités combinées ... 240

Tableau E30 – Rétention – Spécialités combinées ... 241

Tableau E31 – Perte d’efficacité – Oncologie ... 242

Tableau E32 – Immunogénicité – Oncologie ... 243

Tableau E33 – Innocuité – Oncologie ... 244

Tableau E34 – Rétention – Oncologie ... 246

Tableau E35 – Perte d’efficacité – Diabète ... 248

Tableau E36 – Immunogénicité – Diabète ... 251

Tableau E37 – Innocuité – Diabète ... 254

Tableau E38 – Rétention – Diabète ... 257

Tableau E39 – Perte d’efficacité – Hématologie/Néphrologie ... 258

Tableau E40 – Immunogénicité – Hématologie/Néphrologie ... 261

Tableau E41 – Innocuité – Hématologie/Néphrologie ... 262

Tableau E42 – Rétention – Hématologie/Néphrologie ... 264

Tableau E43 – Effets indésirables – Changement de traitement d’un BR vers un BS - Études sans comparateur ... 266

Tableau F1 – Critères d’appréciation de la qualité de la preuve scientifique ... 270

Tableau F2 – Appréciation de la preuve pour la Gastroentérologie ... 272

Tableau F3 – Appréciation de la preuve pour la Rhumatologie ... 275

Tableau F4 – Appréciation de la preuve pour la Dermatologie ... 278

Tableau F5 – Appréciation de la preuve pour l’Oncologie (prévention de la neutropénie) ... 280

Tableau F6 – Appréciation de la preuve pour l’Oncologie (cancer du sein, HER2 positif) ... 282

Tableau F7 – Appréciation de la preuve pour la Hématologie/Néphrologie ... 284

Tableau F8 – Appréciation de la preuve pour l’Endocrinologie (Diabète) ... 286

Tableau F9 – Appréciation de la preuve pour des substitutions multiples ... 288

LISTE DES FIGURES

Figure B1 - Diagramme de flux... 3

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SIGLES ET ABRÉVIATIONS

AACE/ACE American Association of Clinical Endocrinologists and American College of Endocrinology

AAD American Academy of Dermatology Association

AACODS Authority, accuracy, coverage, objectivity, date and significance ACD Association canadienne de dermatologie

ACR American College of Rheumatology

AGES Austria Medecines and Medical Devices Agency

AGREE-GRS Appraisal of guidelines for research and evaluation, Global Rating Scale AP Arthrite psoriasique

ASCO American Society of Clinical Oncology ASPC Agence de la santé publique du Canada BC Cancer British Columbia Cancer

BIRD Belgium Inflammatory Bowel Disease Research and Development Group BR Médicament biologique de référence

BS Médicament biosimilaire

BSR Brazilian Society of Rheumatology

CAG-CCC Canadian Gastroenterology Association et Crohn’s Colitis Canada

CU Colite ulcéreuse

DT1 Diabète de type 1 DT2 Diabète de type 2

EBE European Biopharmaceutical Enterprises ECCO European Crohn’s and Colitis Organisation ECRA Essai comparatif à répartition aléatoire ENCAA Essai non contrôlé avant après

EI Effets indésirables

EIAT Effets indésirables apparus en cours de traitement EIG Effets indésirables graves

EIGAT Effets indésirables graves apparus en cours de traitement EMA European Medicines Agency

ESMO European Society for Medical Oncology

ESPGHAN European Society for Pediatric Gastroenterology, Hepatology and Nutrition EULAR European League Against Rheumatism-People with Arthritis and

Rheumatism

FDA Food and Drug Administration (États-Unis) GPC guide de pratique clinique

HAS Haute Autorité de Santé (France) HIS Healthcare Improvement Scotland (HIS) HKSR Hong Kong Society of Rheumatology

IG-IBD Italian Group for Inflammatory Bowel Disease

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INESSS Institut d’excellence en santé et en services sociaux ISOPP International Society of Oncology Pharmacy Practitioners

MC Maladie de Crohn

MII Maladies inflammatoires de l’intestin

MIInc Maladies inflammatoires de l’intestin, non classées

NICE National Institute for Health and Care Excellence (Royaume-Uni) NRAS National Rheumatoid Arthritis Society (Royaume-Uni)

PNCG Polish National Consultant in Gastroenterology PR Polyarthrite rhumatoïde

Ps Psoriasis en plaques

SA Spondylarthrite ankylosante

SAMAC South Australia Medicines Advisory Committee SBOC Brazilian Health Surveillance Agency

SCR Société canadienne de rhumatologie

SEFH Sociedad Espanola de Farmacia Hospitalaria SFDA Saudi Food and Drug Authority

TNF Facteur de nécrose tumorale

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ANNEXE A

Stratégies de repérage de l’information scientifique

Bases de données bibliographiques

PubMed (NLM)

Date du repérage : décembre 2019 Limites : anglais, français

#1

biosimilar*[tiab] OR bio-similar*[tiab] OR reference product*[tiab] OR reference biologic*[tiab] OR originator*[tiab] OR biological medicine*[tiab] OR biological drug*[tiab] OR biological product*[tiab] OR biologic medicine*[ti] OR biologic drug*[ti] OR biologic product*[ti] OR biomedicament*[ti] OR biologic agent*[ti] OR biopharmaceut*[ti] OR biomedicine*[ti]

#2 switch*[tiab] OR interchang*[tiab] OR substitut*[tiab]

#3 #1 AND #2

#4 guideline*[tiab] OR consensus[tiab] OR position statement*[tiab]

#5 #1 AND #4

#6 #3 OR #5

#7 animal*[tiab] OR mouse[tiab] OR mice[tiab] OR rat[tiab] OR rats[tiab] OR monkey*[tiab] OR rabbit*[tiab]

#8 #6 NOT #7

#9 case report*[tw] OR case serie*[tw] OR case stud*[tw] OR comment[tw] OR editorial[tw] OR letter[tw]

#10 #8 NOT #9

Embase (Ovid)

Date du repérage : décembre 2019

Limites : anglais, français; embase; exclusion périodiques medline 1

(biosimilar* OR bio-similar* OR (reference ADJ2 (product* OR biologic*)) OR (biological ADJ2 (medicine*

OR drug* OR product*)) OR originator*).ti,ab OR ((biologic ADJ2 (medicine* OR drug* OR product* OR agent*)) OR biomedicament* OR biopharmaceut* OR biomedicine*).ti

2 (switch* OR interchang* OR substitut*).ti,ab 3 1 AND 2

4 (guideline* OR consensus OR position statement*).ti,ab 5 1 AND 4

6 3 OR 5

7 (animal* OR mouse OR mice OR rat OR rats OR monkey* OR rabbit*).ti,ab 8 6 NOT 7

9 (case report* OR case serie* OR case stud* OR comment OR editorial OR letter).ti,ab 10 8 NOT 9

EBM Reviews (Ovid) : Cochrane Database of Systematic Reviews; Database of Abstracts of Reviews of Effects; Health Technology Assessment; NHS Economic Evaluation Database

Date du repérage : décembre 2019 Limites : anglais, français

1

(biosimilar* OR bio-similar* OR (reference ADJ2 (product* OR biologic*)) OR (biological ADJ2 (medicine*

OR drug* OR product*)) OR originator*).ti,ab OR ((biologic ADJ2 (medicine* OR drug* OR product* OR agent*)) OR biomedicament* OR biopharmaceut* OR biomedicine*).ti

2 (animal* OR mouse OR mice OR rat OR rats OR monkey* OR rabbit*).ti,ab 3 1 NOT 2

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Sites Web, registres d’essais cliniques, moteurs de recherche et autres bases de données

Date de la consultation : décembre 2019 Limites : anglais et français

• Academic Pediatric Association (https://www.academicpeds.org/)

• Alberta Health (www.alberta.ca/biosimilar-drugs)

• American Academy of Allergy Asthma & Immunology (https://www.acaai.org)

• American Academy of Dermatology Association (https://www.aad.org/)

• American Association of Clinical Endocrinologists (https://www.aace.com/)

• American association of immunologist (https://www.aai.org/)

• American College of Physicians (https://www.acponline.org/)

• American College of Rheumatology (https://www.rheumatology.org)

• American Gastroenterological Association (https://www.gastro.org/)

• American Medical Association (https://www.ama-assn.org/)

• American Pharmacists Association (https://www.pharmacist.com/)

• American Society of Clinical Oncology (https://www.asco.org/)

• ASBM, Alliance for Safe Biologic Medicines (https://safebiologics.org/)

• Association canadienne de dermatologie (https://dermatology.ca/fr/)

• BC Cancer (http://www.bccancer.bc.ca/)

• BC Pharmacare (https://www2.gov.bc.ca/gov/content/health/)

• Canadian Association of Medical Oncologists (https://camo-acom.ca/)

• Canadian Hematology Society (https://canadianhematologysociety.org/)

• Canadian Society for Immunology (https://www.csi-sci.ca/)

• Cancer Care Ontario,

(https://www.smartbiggar.ca/insights/publication/update-on-biosimilars-in-canada-october-2019) (http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/notices/fq_exec_office_20170731.pdf) (http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/notices/fq_exec_office_20160311_1.pdf) (http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/notices/fq_exec_office_20180920_2.pdf)

• ClinicalTrials.gov (clinicaltrials.gov/)

• Diabète Canada (https://www.diabete.qc.ca/fr)

• European Academy of Dermatology (https://www.eadv.org/)

• European Crohn’s Colitis Organization (https://www.ecco-ibd.eu/)

• European Federation of Immunological Societies (https://www.efis.org/)

• European League Against Rheumatism – EULAR (https://www.eular.org/)

• European Society of Endocrinology (https://www.ese-hormones.org/)

• FDA (https://www.fda.gov)

• Generic and Biosimilars initiative (http://gabi-journal.net/what-pricing-and-reimbursement-policies-to-use- for-off-patent-biologicals-in-europe-results-from-the-second-ebe-biological-medicines-policy-survey.html) (www.gabionline.net/Reports/Biosimilar-substitution-in-Europe)

(https://www.centerforbiosimilars.com/conferences/biotech-pharma-summit-biosimilars/regulator-explains- how-denmark-has-achieved-its-biosimilar-success)

(http://gabionline.net/Reports/International-policies-for-interchangeability-switching-and-substitution-of- biosimilars)

• Gouvernement du Nouveau-Brunswick (https://www2.gnb.ca/content/dam/gnb/Departments/h- s/pdf/en/NBDrugPlan/NewBrunswickDrugPlansFormulary.pdf)

• Green Shield (https://www.greenshield.ca/en-ca)

• HAS (https://www.has-sante.fr/)

• International Clinical Trials Registry Platform Search Portal (WHO) (http://apps.who.int/trialsearch/)

• International Society of Oncology Pharmacy Practitioners – ISOPP (https://www.isopp.org/)

• NHS (https://www.nhs.uk/)

• NICE (https://www.nice.org.uk/)

• SAMAC (https://www.sahealth.sa.gov.au/)

• Société canadienne d’endocrinologie et de métabolisme (https://www.endo-metab.ca/)

• Société canadienne de rhumatologie (https://rheum.ca/fr/)

• United European Gastroenterology (https://www.ueg.eu/)

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ANNEXE B

Sélection des documents et listes et raisons des exclusions

Figure B1 - Diagramme de flux

Enregistrements repérés dans les bases de données (n =1677)

Enregistrements repérés dans d’autres sources

(n = 72)

Enregistrements retirés (doublons)

(n = 114)

Enregistrements sélectionnés

(n = 1635)

Enregistrements exclus (n = 1490)

Publications complètes évaluées

(n = 145) Articles complets exclus,

avec les raisons (n = 32)

Doublon, n = 2 Devis inadéquat, n = 2 Absence de résultats d’intérêt, n = 28

Publications incluses (n = 113)

Articles primaire, n = 76 GPC, n = 4 Énoncé de position, n = 33 RepérageSélectionAdmissibilitéInclusion

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Tableau B1 – Liste des documents exclus

Auteur, Année Titre Raison

d’exclusion Alliance for Safe Biologic

Medicines

Fact sheets: Biosimilar Substitution Absence des

résultats d’intérêt Argüelles-Arias, F., et al. Effectiveness and Safety of CT-P13 (Biosimilar Infliximab) in Patients with

Inflammatory Bowel Disease in Real Life at 6 Months Doublon

Ampudia-Blasco, F. J. Biosimilars and Novel Insulins Absence des

résultats d’intérêt Chingcuanco, F., et al. Bioequivalence of Biosimilar Tumor Necrosis Factor-alpha Inhibitors

Compared with Their Reference Biologics: A Systematic Review

Absence des résultats d’intérêt Derwahl, K. M., et al. Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with

Type 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study.

Absence des résultats d’intérêt Diabète Canada Diabetes, Biologic Drugs, and Biosimilar Insulins Devis inadéquat Dormuth, C. R., et al. A rapid monitoring plan following a shift in coverage from brand name to

biosimilar drugs for rheumatoid arthritis in British Columbia Devis inadéquat Flodmark, C. E., et al. Switching from Originator to Biosimilar Human Growth Hormone Using

Dialogue Teamwork: Single-Center Experience From Sweden

Absence des résultats d’intérêt Fonseca, J. E., et al. The Portuguese Society of Rheumatology position paper on the use of

biosimilars Doublon

Gerdes, S., et al. Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study

Absence des résultats d’intérêt Goncalves, J., et al. Antigenic response to CT-P13 and infliximab originator in inflammatory

bowel disease patients shows similar epitope recognition

Absence des résultats d’intérêt Hlavaty, T., et al. Biosimilar infliximab CT-P13 treatment in patients with inflammatory bowel

diseases – a one-year, single-centre retrospective study

Absence des résultats d’intérêt Hu, X., et al. Switching from biosimilar (Basalin) to originator (Lantus) insulin glargine is

effective in Chinese patients with diabetes mellitus: A retrospective chart review

Biosimilaire non approuvé au

Canada Huoponen, S., et al. Health-related quality of life and costs of switching originator infliximab to

biosimilar one in treatment of inflammatory bowel disease

Absence des résultats d’intérêt Ingrasciotta, Y., et al. In Search of Predictors of Switching Between Erythropoiesis-Stimulating

Agents in Clinical Practice: A Multi-Regional Cohort Study

Absence des résultats d’intérêt International Coalition of

Medicines Regulatory Authorities

ICMRA statement about confidence in biosimilar products (for patients and

the public) Absence des

résultats d’intérêt Ilias, A., et al. Outcomes of Patients with Inflammatory Bowel Diseases Switched from

Maintenance Therapy with a Biosimilar to Remicade®

Absence des résultats d’intérêt Ito, H., et al. A comparison of the clinical courses of type 2 diabetic patients whose basal

insulin preparation was replaced from insulin glargine 100 units/mL to insulin glargine biosimilar or 300 units/mL: A propensity score-matched observation study

Absence des résultats d’intérêt Kolberg, H. C., et al. Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with

HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study

Absence des résultats d’intérêt Lee, S., et al. Comparative Efficacy and Safety of Biosimilar Rituximab and Originator

Rituximab in Rheumatoid Arthritis and Non-Hodgkin's Lymphoma:

A Systematic Review and Meta-analysis

Absence des résultats d’intérêt Llag, L. L., et al. Evaluation of immunogenicity of LY2963016 insulin glargine compared with

Lantus® insulin glargine in patients with type 1 or type 2 diabetes mellitus

Absence des résultats d’intérêt Nguyen, E., et al. Impact of non-medical switching on clinical and economic outcomes,

resource utilization and medication-taking behavior: A systematic literature review

Absence des résultats d’intérêt

NICE Biosimilar medicines Absence des

résultats d’intérêt Otha, S., et al. Efficacy of once or twice weekly administration of epoetin κ in patients

receiving hemodialysis: A retrospective study

Absence des résultats d’intérêt Panaccione, R., et al. Clinical practice guidelines: Canadian Association of Gastroenterology

Clinical Practice Guideline for the Management of Luminal Crohn’s Disease Absence des résultats d’intérêt Rashid, N., et al. Switching to Omnitrope from Other Recombinant Human Growth Hormone

Therapies: A Retrospective Study in an Integrated Healthcare System

Absence des résultats d’intérêt Renton, W. D., et al. Same but different? A thematic analysis on adalimumab biosimilar switching

among patients with juvenile idiopathic arthritis

(17)

Auteur, Année Titre Raison d’exclusion Segal, D., et al. The Biosulin equivalence in standard therapy (BEST) study − a multicentre,

open-label, non-randomised, interventional, observational study in subjects using Biosulin 30/70 for the treatment of insulin-dependent type 1 and type 2 diabetes mellitus

Absence des résultats d’intérêt Sharma, A., et al. Immunogenicity and efficacy after switching from original Ranibizumab to a

Ranibizumab biosimilar: Real-world data

Absence des résultats d’intérêt Stubbs, M. J., et al. Comparison of Rituximab originator (MabThera) to biosimilar (Truxima) in

patients with immune-mediated thrombotic thrombocytopenic purpura

Absence des résultats d’intérêt Verpoort, K., et al. A non-interventional study of biosimilar granulocyte colony-stimulating

factor as prophylaxis for chemotherapy-induced neutropenia in a community oncology centre

Absence des résultats d’intérêt Wiecek, A., et al. Switching Epoetin Alfa and Epoetin Zeta in Patients with Renal Anemia on

Dialysis: Posthoc Analysis

(18)

Tableau B2 – Liste des documents inclus

Identification Référence Pathologie Molécule

Biologique Devis

Raison d’inclusion

Efficacité Immunogénicité Innocuité Rétention Recommandations

Articles primaires

Abdalla et al., 2017

Abdalla A, Byrne N, Conway R, Walsh T, Mannion G, Hanly M, et al.

Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product. Open Access Rheumatol 2017;9:29-35

PR, AP, SA Infliximab ENCAA

✓

Alten et al., 2019

Alten R, Batko B, Hala T, Kameda H, Radominski SC, Tseluyko V, et al.

Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: Efficacy, safety and immunogenicity from week 30 to week 54. RMD Open 2019;5(1):e000876

PR Infliximab ECRA

✓ ✓ ✓

Argüelles-Arias et al., 2017

Argüelles-Arias F, Guerra Veloz MF, Perea Amarillo R, Vilches-Arenas A, Castro Laria L, Maldonado Perez B, et al. Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results. Eur J Gastroenterol Hepatol 2017a;29(11):1290-5

MC, CU Infliximab ENCAA

✓

Avouac et al., 2018

Avouac J, Molto A, Abitbol V, Etcheto A, Salcion A, Gutermann L, et al.

Systematic switch from innovator infliximab to biosimilar infliximab in inflammatory chronic diseases in daily clinical practice: The experience of Cochin University Hospital, Paris, France. Semin Arthritis Rheum 2018;47(5):741-8

PR, SA, MC, CU Infliximab ENCAA

✓

Belleudi et al., 2019

Belleudi V, Trotta F, Addis A, Ingrasciotta Y, Ientile V, Tari M, et al.

Effectiveness and safety of switching originator and biosimilar epoetins in patients with chronic kidney disease in a large-scale Italian cohort study. Drug Saf 2019;42(12):1437-47

Anémie Epoetin Cohortes

rétrospectives

✓ ✓

Benucci et al., 2017

Benucci M, Gobbi FL, Bandinelli F, Damiani A, Infantino M, Grossi V, et al. Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: A 6-month real-life observational study. Immunol Res 2017;65(1):419-22

SA Infliximab ENCAA

✓

Bergqvist et al., 2018

Bergqvist V, Kadivar M, Molin D, Angelison L, Hammarlund P, Olin M, et al. Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease. Therap Adv Gastroenterol 2018;11:1756284818801244

✓

Blackwell et al., 2018

Blackwell K, Gascon P, Krendyukov A, Gattu S, Li Y, Harbeck N. Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: A phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol 2018;29(1):244-9

Neutropénie Filgrastim ECRA

✓ ✓ ✓ ✓

(19)

Identification Référence Pathologie Molécule

Biologique Devis

Blauvelt et al., 2018

Blauvelt A, Lacour JP, Fowler JF Jr, Weinberg JM, Gospodinov D, Schuck E, et al. Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: Impact of multiple switches. Br J Dermatol 2018;179(3):623-31

Ps Adalimumab ECRA

✓ ✓ ✓

Blevins et al., 2019

Blevins TC, Barve A, Raiter Y, Aubonnet P, Athalye S, Sun B, Muniz R.

Efficacy and safety of MYL-1501D versus insulin glargine in patients with type 1 diabetes mellitus: Results of the INSTRIDE 3 phase 3 switch study. Diabetes Obes Metab 2019;21(1):129-35

DT1 Insuline ECRA

✓ ✓ ✓ ✓

Bonifati et al., 2019

Bonifati C, De Felice C, Lora V, Morrone A, Graceffa D. Effectiveness of etanercept biosimilar SB4 in maintaining low disease activity in patients with psoriatic arthritis switched from etanercept originator: An open-label one-year study. J Dermatolog Treat 2019 [Epub ahead of print]

AP Etanercept ENCAA

✓

Bronswijk et al., 2020

Bronswijk M, Moens A, Lenfant M, Tops S, Compernolle G, Van Assche G, et al. Evaluating efficacy, safety, and pharmacokinetics after switching from infliximab originator to biosimilar CT-P13: Experience from a large tertiary referral center. Inflamm Bowel Dis 2019;26(4):628-34

✓

Buer et al., 2017

Buer LC, Moum BA, Cvancarova M, Warren DJ, Medhus AW, Hoivik ML.

Switching from Remicade® to Remsima® is well tolerated and feasible:

A prospective, open-label study. J Crohns Colitis 2017;11(3):297-304

✓

Cohen et al., 2020

Cohen SB, Radominski SC, Kameda H, Kivitz AJ, Tee M, Cronenberger C, et al. Long-term efficacy, safety, and immunogenicity of the infliximab (IFX) biosimilar, PF-06438179/GP1111, in patients with rheumatoid arthritis after switching from reference IFX or continuing biosimilar therapy: Week 54-78 data from a randomized, double-blind, phase III trial. BioDrugs 2020;34(2):197-207.

PR Infliximab ECRA +

extension

✓

Cohen et al., 2018

Cohen SB, Alonso-Ruiz A, Klimiuk PA, Lee EC, Peter N, Sonderegger I, Assudani D. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: Results from the phase III randomised VOLTAIRE-RA equivalence study. Ann Rheum Dis 2018;77(6):914-21

PR Adalimumab ECRA

✓ ✓ ✓

Eberl et al., 2017

Eberl A, Huoponen S, Pahikkala T, Blom M, Arkkila P, Sipponen T.

Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients. Scand J Gastroenterol 2017;52(12):1348-53

MC, CU, MIInc Infliximab ENCAA

✓

Emery et al., 2017 Emery P, Vencovsky J, Sylwestrzak A, Leszczynski P, Porawska W,

Stasiuk B, et al. Long-term efficacy and safety in patients with PR Etanercept ECRA +

extension

✓

(20)

Identification Référence Pathologie Molécule

Biologique Devis

rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4. Ann Rheum Dis 2017;76:1986-91

Fabiani et al., 2019

Fabiani C, Vitale A, Emmi G, Sgheri A, Lopalco G, Sota J, et al. The role of biosimilars in uveitis: Long-term real-world outcomes of the switch from original to biosimilar TNF-alpha inhibitors. Front Pharmacol 2019;10:1468

Uvéite TNF Inhibiteur Cohorte

rétrospective

✓

Felis-Giemza et al., 2019

Felis-Giemza A, Chmurzynska K, Nalecz-Janik J, Romanowska- Prochnicka K, Swierkocka K, Wudarski M, Olesinska M. Observational study of inflammatory arthritis treatment by etanercept originator switched to an etanercept biosimilar. Reumatologia 2019;57(5):257-63

PR, SA, AP Etanercept ENCAA

✓

Fiorino et al., 2018

Fiorino G, Ruiz-Arguello MB, Maguregui A, Nagore D, Correale C, Radice S, et al. Full interchangeability in regard to immunogenicity between the infliximab reference biologic and biosimilars CT-P13 and SB2 in inflammatory bowel disease. Inflamm Bowel Dis 2018;24(3):601-6

✓

Genovese et al., 2019

Genovese MC, Glover J, Greenwald M, Porawska W, El Khouri EC, Dokoupilova E, et al. FKB327, an adalimumab biosimilar, versus the reference product: Results of a randomized, Phase III, double-blind study, and its open-label extension. Arthritis Res Ther 2019;21(1):281

PR Adalimumab ECRA +

extension

✓ ✓

Gervais et al., 2018

Gervais L, McLean LL, Wilson ML, Cameron C, Curtis L, Garrick V, et al.

Switching from originator to biosimilar infliximab in paediatric inflammatory bowel disease is feasible and uneventful. J Pediatr Gastroenterol Nutr 2018;67(6):745-8

✓

Glintborg et al., 2019

Glintborg B, Loft AG, Omerovic E, Hendricks O, Linauskas A, Espesen J, et al. To switch or not to switch: Results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis 2019;78(2):192-200

PR, AP, SA Etanercept

Cohorte rétrospective

et historique

✓ ✓

Glintborg et al., 2017

Glintborg B, Sorensen IJ, Loft AG, Lindegaard H, Linauskas A, Hendricks O, et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis:

1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis 2017;76(8):1426-31

PR, AP, SA Infliximab

Cohorte rétrospective

et historique

✓ ✓

Goll et al., 2019

Goll GL, Jorgensen KK, Sexton J, Olsen IC, Bolstad N, Haavardsholm EA, et al. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: Open-label extension of the NOR-SWITCH trial. J Intern Med 2019;285(6):653-69

PR, AP, SA, Ps,

MC, CU Infliximab ECRA +

extension

✓

Griffiths et al., 2017

Griffiths CE, Thaci D, Gerdes S, Arenberger P, Pulka G, Kingo K, et al.

The EGALITY study: A confirmatory, randomized, double-blind study Ps Etanercept ECRA

✓ ✓ ✓

(21)

Identification Référence Pathologie Molécule

Biologique Devis

comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol 2017;176(4):928-38

Guerra Veloz et al., 2019

Guerra Veloz MF, Belvis Jimenez M, Valdes Delgado T, Castro Laria L, Maldonado Perez B, Perea Amarillo R, et al. Long-term follow up after switching from original infliximab to an infliximab biosimilar: Real-world data. Therap Adv Gastroenterol 2019;12:1756284819858052

✓

Guerra Veloz et al., 2018a

Guerra Veloz MF, Argüelles-Arias F, Castro Laria L, Maldonado Perez B, Benitez Roldan A, Perea Amarillo R, et al. Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar (CT-P13) in patients with inflammatory bowel disease. World J Gastroenterol 2018a;24(46):5288-96

MC, CU Infliximab

Cohortes rétrospective

et prospective

✓ ✓ ✓

Guerra Veloz et al., 2018b

Guerra Veloz MF, Vazquez Moron JM, Belvis Jimenez M, Pallares Manrique H, Valdes Delgado T, Castro Laria L, et al. Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: Results of a multicenter study after 12 months. Rev Esp Enferm Dig 2018b;110(9):564-70

✓

Guerrero Puente et al., 2017

Guerrero Puente L, Iglesias Flores E, Benitez JM, Medina Medina R, Salgueiro Rodriguez I, Aguilar Melero P, et al. Evolution after switching to biosimilar infliximab in inflammatory bowel disease patients in clinical remission. Gastroenterol Hepatol 2017;40(9):595-604

✓

Guiotto et al., 2019

Guiotto C, Italia A, Lavagna A, Rigazio C, Cosimato M, Ercole E, et al.

Switching from infliximab originator to a first biosimilar is safe and effective. Results of a case-control study with drug levels and antibodies evaluation. Dig Liver Dis 2019;51(8):1117-22

✓

Haag-Weber et al., 2009

Haag-Weber M, Vetter A, Thyroff-Friesinger U. Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol 2009;72(5):380-90

Anémie Epoetin ECRA +

extension

✓ ✓ ✓

Hadjiyianni et al., 2016

Hadjiyianni I, Dahl D, Lacaya LB, Pollom RK, Chang CL, Ilag LL. Efficacy and safety of LY2963016 insulin glargine in patients with type 1 and type 2 diabetes previously treated with insulin glargine. Diabetes Obes Metab 2016;18(4):425-9

DT1, DT2 Insuline ECRA

✓ ✓ ✓

Hercogova et al., 2020

Hercogova J, Papp KA, Chyrok V, Ullmann M, Vlachos P, Edwards CJ.

AURIEL-PsO: A randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022

Ps Adalimumab ECRA

✓ ✓ ✓ ✓

(22)

Identification Référence Pathologie Molécule

Biologique Devis

to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol 2020;182(2):316-26

Hoivik et al., 2018

Hoivik ML, Buer LCT, Cvancarova M, Warren DJ, Bolstad N, Moum BA, Medhus AW. Switching from originator to biosimilar infliximab – Real world data of a prospective 18 months follow-up of a single-centre IBD population. Scand J Gastroenterol 2018;53(6):692-9

✓

Jaworski et al., 2019

Jaworski J, Matucci-Cerinic M, Schulze-Koops H, Buch MH, Kucharz EJ, Allanore Y, et al. Switch from reference etanercept to SDZ ETN, an etanercept biosimilar, does not impact efficacy, safety, and immunogenicity of etanercept in patients with moderate-to-severe rheumatoid arthritis: 48-week results from the phase III, randomized, double-blind EQUIRA study. Arthritis Res Ther 2019;21(1):130

PR Etanercept ECRA +

extension

✓

Jorgensen et al., 2017

Jorgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N,

Haavardsholm EA, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): A 52-week, randomised, double-blind, non-inferiority trial. Lancet 2017;389(10086):2304-16

PR, AP, SA, Ps,

MC, UC Infliximab ECRA

✓ ✓ ✓ ✓

Kaltsonoudis et al., 2019

Kaltsonoudis E, Pelechas E, Voulgari PV, Drosos AA. Maintained clinical remission in ankylosing spondylitis patients switched from reference infliximab to its biosimilar: An 18-month comparative open-label study.

J Clin Med 2019;8(7):956

SA Infliximab Cohortes

prospectives

✓ ✓ ✓

Kang et al., 2018

Kang B, Lee Y, Lee K, Choi YO, Choe YH. Long-term outcomes after switching to CT-P13 in pediatric-onset inflammatory bowel disease:

A single-center prospective observational study. Inflamm Bowel Dis 2018;24(3):607-16

MC, CU Infliximab Cohortes

prospectives

✓ ✓ ✓ ✓

Kolar et al., 2017

Kolar M, Duricova D, Bortlik M, Hruba V, Machkova N, Mitrova K, et al.

Infliximab biosimilar (Remsima^TM) in therapy of inflammatory bowel diseases patients: Experience from one tertiary inflammatory bowel diseases centre. Dig Dis 2017;35(1-2):91-100

✓

Lukas et al., 2020

Lukas M, Malickova K, Kolar M, Bortlik M, Vasatko M, Machkova N, et al.

Switching from originator adalimumab to the biosimilar SB5 in patients with inflammatory bowel disease: Short-term experience from a single tertiary clinical center. J Crohns Colitis 2020[Epub ahead of print]

MC, CU, MIInc Adalimumab Cohortes

rétrospectives

✓ ✓

Matsuno et Matsubara, 2019

Matsuno H et Matsubara T. A randomized double-blind parallel-group phase III study to compare the efficacy and safety of NI-071 and infliximab reference product in Japanese patients with active rheumatoid arthritis refractory to methotrexate. Mod Rheumatol 2019;29(6):919-27

extension

✓

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Identification Référence Pathologie Molécule

Biologique Devis

Minutolo et al., 2017

Minutolo R, Bolasco P, Chiodini P, Sposini S, Borzumati M, Abaterusso C, et al. Effectiveness of switch to erythropoiesis-stimulating agent (ESA) biosimilars versus maintenance of ESA originators in the real-life setting:

Matched-control study in hemodialysis patients. Clin Drug Investig 2017;37(10):965-73

Anémie Epoetin Cohortes

rétrospectives

✓

Nikiphorou et al., 2015

Nikiphorou E, Kautiainen H, Hannonen P, Asikainen J, Kokko A, Rannio T, Sokka T. Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther 2015;15(12):1677-83

PR, AP, SA Infliximab ENCAA

✓

Papp et al., 2017

Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, et al.

Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol 2017;76(6):1093-102

Ps Adalimumab ECRA

✓ ✓ ✓ ✓

Park et al., 2017a

Park W, Suh CH, Shim SC, Molina FFC, Jeka S, Medina-Rodriguez FG, et al. Efficacy and safety of switching from innovator rituximab to biosimilar CT-P10 compared with continued treatment with CT-P10:

Results of a 56-week open-label study in patients with rheumatoid arthritis. BioDrugs 2017a;31(4):369-77

PR Rituximab ECRA +

extension

✓

Park et al., 2017b

Park W, Yoo DH, Miranda P, Brzosko M, Wiland P, Gutierrez-Ureña S, et al. Efficacy and safety of switching from reference infliximab to CT- P13 compared with maintenance of CT-P13 in ankylosing spondylitis:

102-week data from the PLANETAS extension study. Ann Rheum Dis 2017b;76(2):346-54

extension

✓

Pescitelli et al., 2019

Pescitelli L, Lazzeri L, Di Cesare A, Tripo L, Ricceri F, Prignano F.

Clinical experience with the etanercept biosimilar SB4 in psoriatic patients. Int J Clin Pharm 2019;41(1):9-12

PR, Ps Etanercept ENCAA

✓

Petitdidier et al., 2019

Petitdidier N, Tannoury J, de'Angelis N, Gagniere C, Hulin A, Rotkopf H, et al. Patients' perspectives after switching from infliximab to biosimilar CT-P13 in patients with inflammatory bowel disease: A 12-month prospective cohort study. Dig Liver Dis 2019;51(12):1652-60

✓

Plevris et al., 2019

Plevris N, Jones GR, Jenkinson PW, Lyons M, Chuah CS, Merchant LM, et al. Implementation of CT-P13 via a managed switch programme in Crohn's disease: 12-month real-world outcomes. Dig Dis Sci 2019;64(6):1660-7

✓

Ratnakumaran et al., 2018

Ratnakumaran R, To N, Gracie DJ, Selinger CP, O'Connor A, Clark T, et

al. Efficacy and tolerability of initiating, or switching to, infliximab MC, CU Infliximab Cohortes

prospectives

✓ ✓

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Identification Référence Pathologie Molécule

Biologique Devis

biosimilar CT-P13 in inflammatory bowel disease (IBD): A large single- centre experience. Scand J Gastroenterol 2018;53(6):700-7

Razanskaite et al., 2017

Razanskaite V, Bettey M, Downey L, Wright J, Callaghan J, Rush M, et al. Biosimilar infliximab in inflammatory bowel disease: Outcomes of a managed switching programme. J Crohns Colitis 2017;11(6):690-6

✓

Rosenstock et al., 2015

Rosenstock J, Hollander P, Bhargava A, Ilag LL, Pollom RK, Zielonka JS, et al. Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naive or previously treated with insulin glargine: A randomized, double-blind controlled trial (the ELEMENT 2 study). Diabetes Obes Metab 2015;17(8):734-41

DT2 Insuline ECRA

✓

Scherlinger et al., 2018

Scherlinger M, Germain V, Labadie C, Barnetche T, Truchetet ME, Bannwarth B, et al. Switching from originator infliximab to biosimilar CT- P13 in real-life: The weight of patient acceptance. Joint Bone Spine 2018;85(5):561-7

PR, SA Infliximab

Cohortes prospective et

rétrospective

✓

Schmitz et al., 2017

Schmitz EM, Benoy-De Keuster S, Meier AJ, Scharnhorst V, Traksel RA, Broeren MA, Derijks LJ. Therapeutic drug monitoring (TDM) as a tool in the switch from infliximab innovator to biosimilar in rheumatic patients:

Results of a 12-month observational prospective cohort study. Clin Rheumatol 2017;36(9):2129-34

PR, AP, SA, PR+CU, Periferal arthritis+CU

Infliximab ENCAA

✓

Schmitz et al., 2018

Schmitz EM, Boekema PJ, Straathof JW, van Renswouw DC, Brunsveld L, Scharnhorst V, et al. Switching from infliximab innovator to biosimilar in patients with inflammatory bowel disease: A 12-month multicentre observational prospective cohort study. Aliment Pharmacol Ther 2018;47(3):356-63

✓

Shim et al., 2019

Shim SC, Bozic-Majstorovic L, Berrocal Kasay A, El-Khouri EC, Irazoque-Palazuelos F, Cons Molina FF, et al. Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis:

72-week data from a randomized Phase 3 trial. Rheumatology (Oxford) 2019;58(12):2193-202

PR Rituximab ECRA

✓ ✓ ✓ ✓

Sieczkowska et al., 2016

Sieczkowska J, Jarzebicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska E, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease.

Preliminary observations. J Crohns Colitis 2016;10(2):127-32

✓

Smits et al., 2019

Smits LJ, van Esch AA, Derikx LA, Boshuizen R, de Jong DJ, Drenth JP, Hoentjen F. Drug survival and immunogenicity after switching from Remicade to biosimilar CT-P13 in inflammatory bowel disease patients:

✓

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Identification Référence Pathologie Molécule

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Two-year follow-up of a prospective observational cohort study. Inflamm Bowel Dis 2019;25(1):172-9

Smits et al., 2017

Smits LJ, Grelack A, Derikx LA, de Jong DJ, van Esch AA, Boshuizen RS, et al. Long-term clinical outcomes after switching from Remicade®

to biosimilar CT-P13 in inflammatory bowel disease. Dig Dis Sci 2017;62(11):3117-22

✓

Smits et al., 2016

Smits LJ, Derikx LA, de Jong DJ, Boshuizen RS, van Esch AA, Drenth JP, Hoentjen F. Clinical outcomes following a switch from Remicade® to the biosimilar CT-P13 in inflammatory bowel disease patients:

A prospective observational cohort study. J Crohns Colitis 2016;10(11):1287-93

✓

Smolen et al., 2018

Smolen JS, Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, et al. Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis:

Results of a randomised, double-blind, phase III transition study. Ann Rheum Dis 2018;77(2):234-40

PR Infliximab ECRA

✓ ✓ ✓ ✓

Strik et al., 2018

Strik AS, van de Vrie W, Bloemsaat-Minekus JP, Nurmohamed M, Bossuyt PJ, Bodelier A, et al. Serum concentrations after switching from originator infliximab to the biosimilar CT-P13 in patients with quiescent inflammatory bowel disease (SECURE): An open-label, multicentre, phase 4 non- inferiority trial. Lancet Gastroenterol Hepatol 2018;3(6):404-12

MC, CU Infliximab ECRA

✓

Tanaka et al., 2017

Tanaka Y, Yamanaka H, Takeuchi T, Inoue M, Saito K, Saeki Y, et al.

Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab. Mod Rheumatol 2017;27(2):237-45

extension

✓

Thadhani et al., 2018

Thadhani R, Guilatco R, Hymes J, Maddux FW, Ahuja A. Switching from epoetin alfa (Epogen®) to epoetin alfa-epbx (RetacritTM) using a specified dosing algorithm: A randomized, non-inferiority study in adults on hemodialysis. Am J Nephrol 2018;48(3):214-24

Anémie Epoetin ECRA

✓ ✓ ✓

Tony et al., 2019

Tony HP, Krüger K, Cohen SB, Schulze-Koops H, Kivitz AJ, Jeka S, et al. Brief report: Safety and immunogenicity of rituximab biosimilar GP 2013 after switch from reference rituximab in patients with active rheumatoid arthritis. Arthritis Care Res (Hoboken) 2019;71(1):88-94

PR Rituximab ECRA

✓ ✓

Tweehuysen et al., 2018a

Tweehuysen L, Huiskes VJ, van den Bemt BJ, Vriezekolk JE, Teerenstra

S, van den Hoogen FHJ, et al. Open-label, non-mandatory transitioning PR, AP, SA Etanercept

Cohortes prospective et

historique

✓ ✓ ✓

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Identification Référence Pathologie Molécule

Biologique Devis

from originator etanercept to biosimilar SB4: Six-month results from a controlled cohort study. Arthritis Rheumatol 2018a;70(9):1408-18 Tweehuysen et

al., 2018b

Tweehuysen L, van den Bemt BJ, van Ingen IL, de Jong AJ, van der Laan WH, van den Hoogen FH, den Broeder AA. Subjective complaints as the main reason for biosimilar discontinuation after open-label transition from reference infliximab to biosimilar infliximab. Arthritis Rheumatol 2018b;70(1):60-8

PR, AP, SA Infliximab Cohorte

prospective

✓

Van Hoeve et al., 2019

Van Hoeve K, Dreesen E, Hoffman I, Van Assche G, Ferrante M, Gils A, Vermeire S. Efficacy, Efficacy, pharmacokinetics and immunogenicity is not affected by switching from infliximab originator to a biosimilar in pediatric patients with inflammatory bowel disease. Ther Drug Monit 2019;41(3):317-24

MC, CU Infliximab

Cohortes rétrospective

et prospective

✓ ✓

Vergara-Dangond et al., 2017

Vergara-Dangond C, Saez Bello M, Climente Marti M, Llopis Salvia P, Alegre-Sancho JJ. Effectiveness and safety of switching from innovator infliximab to biosimilar CT-P13 in inflammatory rheumatic diseases:

A real-world case study. Drugs R D 2017;17(3):481-5

PR, AP, SA Infliximab Cohortes

prospectives

✓ ✓ ✓

Von Minckwitz et al., 2018

Von Minckwitz G, Colleoni M, Kolberg HC, Morales S, Santi P, Tomasevic Z, et al. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): A randomised, double-blind, phase 3 trial. Lancet Oncol 2018;19(7):987-98

Cancer sein Trastuzumab ECRA

✓ ✓

Weinblatt et al., 2018

Weinblatt ME, Baranauskaite A, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, et al. Switching from reference adalimumab to SB5 (adalimumab biosimilar) in patients with rheumatoid arthritis: Fifty-two- week phase III randomized study results. Arthritis Rheumatol 2018;70(6):832-40

PR Adalimumab ECRA

✓ ✓ ✓ ✓

Yamanaka et al., 2020

Yamanaka H, Kamatani N, Tanaka Y, Hibino T, Drescher E, Sanchez- Burson J, et al. A comparative study to assess the efficacy, safety, and immunogenicity of YLB113 and the etanercept reference product for the treatment of patients with rheumatoid arthritis. Rheumatol Ther 2020;7(1):149-63

PR Adalimumab ECRA +

extension

✓ ✓

Yazici et al., 2018

Yazici Y, Xie L, Ogbomo A, Ellis LA, Goyal K, Teeple A, Simsek I.

Analysis of real-world treatment patterns in a matched rheumatology population that continued innovator infliximab therapy or switched to biosimilar infliximab. Biologics 2018;12:127-34

PR Infliximab Cohortes

rétrospectives

✓

Ye et al., 2019

Ye BD, Pesegova M, Alexeeva O, Osipenko M, Lahat A, Dorofeyev A, et al. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: An international,

MC Infliximab ECRA

✓ ✓ ✓ ✓

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randomised, double-blind, phase 3 non-inferiority study. Lancet 2019;393(10182):1699-707.

Yoo et al., 2017

Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre E, Lanzon A, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: Comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis 2017;76(2):355-63

extension

✓

Guide de pratique clinique (GPC)

Araujo et al., 2017

Araujo FC, Sepriano A, Teixeira F, Jesus D, Rocha TM, Martins P, et al.

The Portuguese Society of Rheumatology position paper on the use of biosimilars – 2017 update. Acta Reumatol Port 2017;42(3):219-28

GPC

✓

Kay et al., 2018

Kay J, Schoels MM, Dorner T, Emery P, Kvien TK, Smolen JS, et al.

Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis 2018;77(2):165-74

GPC

✓

Ward et al., 2019

2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol 2019;71(10):1599-613

GPC

✓

Xibille et al., 2018

Xibille D, Carrillo S, Huerta-Sil G, Hernandez R, Limon L, Olvera-Soto G, et al. Current state of biosimilars in Mexico: The position of the Mexican College of Rheumatology, 2016. Reumatol Clin 2018;14(3):127-36

GPC

✓

Énoncé de position

AAD, 2013 American Academy of Dermatology (AAD). Position statement on generic therapeutic and biosimilar substitution. Rosemont, IL : AAD; 2013. Disponible à : https://server.aad.org/forms/policies/uploads/ps/ps-generic%20therapeutic%20and%20%20biosimilar%20substitution.pdf.

ACD, 2013 Association canadienne de dermatologie (ACD). Énoncé de principe de l'Association canadienne de dermatologie : les biosimilaires. Ottawa, ON : ACD; 2013.

Disponible à : https://dermatology.ca/wp-content/uploads/2013/09/Biosimilars-WEB-FR-2013.pdf.

ACR, 2018 American College of Rheumatology (ACR). Position statement: Biosimilars. Atlanta, GA : ACR; 2018. Disponible à : https://www.rheumatology.org/Portals/0/Files/Biosimilars-Position-Statement.pdf?ver=2018-05-21-134110-000.

Azevedo et al., 2015

Azevedo VF, Meirelles Ede S, Kochen Jde A, Medeiros AC, Miszputen SJ, Teixeira FV, et al. Recommendations on the use of biosimilars by the Brazilian Society of Rheumatology, Brazilian Society of Dermatology, Brazilian Federation of Gastroenterology and Brazilian Study Group on Inflammatory Bowel Disease—Focus on clinical evaluation of monoclonal antibodies and fusion proteins used in the treatment of autoimmune diseases. Autoimmun Rev 2015;14(9):769-73.

Baumgärtel, 2017 Baumgärtel C. Austrian medicines authority positive towards biosimilar interchangeability. Generics and Biosimilars Initiative Journal 2017;6(1):41.

Biosimilar Medicines, 2019

Biosimilar Medicines. Positioning statements on physician-led switching for biosimilar medicines. Bruxelles, Belgique : Medicines for Europe; 2019. Disponible à : https://www.medicinesforeurope.com/wp-content/uploads/2017/03/M-Biosimilars-Overview-of-positions-on-physician-led-switching.pdf.

Diabetes Canada, 2019

Diabetes Canada. Diabetes, biologic drugs, and biosimilar insulins [site Web]. Toronto, ON : Diabetes Canada; 2019. Disponible à :

https://www.diabetes.ca/advocacy---policies/our-policy-positions/diabetes,-biologic-drugs,-and-biosimilar-insulins (consulté le 23 janvier 2020).

(28)

Identification Référence Pathologie Molécule

Biologique Devis

Danese et al., 2017

Danese S, Fiorino G, Raine T, Ferrante M, Kemp K, Kierkus J, et al. ECCO position statement on the use of biosimilars for inflammatory bowel disease—An update. J Crohns Colitis 2017;11(1):26-34.

De Ridder et al., 2019

De Ridder L, Assa A, Bronsky J, Romano C, Russell RK, Afzal NA, et al. Use of biosimilars in pediatric inflammatory bowel disease: An updated position statement of the Pediatric IBD Porto Group of ESPGHAN. J Pediatr Gastroenterol Nutr 2019;68(1):144-53.

EMA, 2017 European Medicines Agency (EMA). Guideline on immunogenicity assessment of therapeutic proteins. Londres, Angleterre : EMA; 2017. Disponible à : https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf.

FDA, 2017 Food and Drug Administration (FDA). Prescribing biosimilar products. Silver Spring, MD : FDA; 2017. Disponible à : https://www.fda.gov/media/108103/download.

Fernandes et al., 2018

Fernandes GS, Sternberg C, Lopes G, Chammas R, Gifoni MAC, Gil RA, Araujo DV. TThe use of biosimilar medicines in oncology – Position statement of the Brazilian Society of Clinical Oncology (SBOC). Braz J Med Biol Res 2018;51(3):e7214.

Fiorino et al., 2018

Fiorino G, Caprioli F, Daperno M, Mocciaro F, Principi M, Viscido A, et al. Use of biosimilars in inflammatory bowel disease: A position update of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD). Dig Liver Dis 2019;51(5):632-9.

Fonseca et al., 2017

Fonseca VA, Bloomgarden ZT, Dagogo-Jack S, Grunberger G, Einhorn D, Garber AJ, et al. AACE/ACE position statement on the use of follow-on biologics and biosimilars for endocrine diseases. Endocr Pract 2017;23(11):1345-9.

Franchimont et al., 2018

Franchimont D, Ferrante M, Louis E, De Vos M, Dewit O, Van Hootegem P, et al. Belgian IBD research group (BIRD) position statement 2017 on the use of biosimilars in inflammatory bowel diseases (IBD). Acta Gastroenterol Belg 2018;81(1):49-53.

Halabi et al., 2018 Halabi H, Zahrani ZA, Swailem RA, Husain W, Rayes HA, Osaimi HA, et al. Biosimilars in rheumatic diseases: Regulatory guidelines, efficacy and safety implications in Saudi Arabia. Open Rheumatol J 2018;12(1):313-22.

HAS, 2017 Haute Autorité de Santé (HAS). Bon usage du médicament – Les médicaments biosimilaires. Saint-Denis La Plaine, France : HAS; 2017. Disponible à : https://www.has-sante.fr/upload/docs/application/pdf/2017-11/bum_medicaments_biosimilaires_v1.pdf.

HIS, 2018 Healthcare Improvement Scotland (HIS). Biosimilar medicines: A national prescribing framework. Édimbourg, Écosse : HIS; 2018.Disponible à : http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/programme_resources/biosimilar_medicines_framework.aspx.

Ho et al., 2019 Ho CT, Mok CC, Cheung TT, Kwok KY, Yip RM. Management of rheumatoid arthritis: 2019 updated consensus recommendations from the Hong Kong Society of Rheumatology. Clin Rheumatol 2019;38(12):3331-50.

ISOPP, 2019

International Society of Oncology Pharmacy Practioners (ISOPP). ISOPP global position on the use of biosimilars in cancer treatment and supportive care.

Vancouver, BC : ISOPP; 2019. Disponible à :

https://www.isopp.org/sites/default/files/resource/files/ISOPP%20Global%20Position%20on%20the%20Use%20of%20Biosimilars.pdf.

Jahnz-Rozyk et al., 2019

Jahnz-Rozyk K, Brzosko M, Lech-Maranda E, Narbutt J, Owczarek W, Rekas M, et al. The Polish Expert Group position statement on the safety of biological treatments with monoclonal antibodies and fusion proteins: An update. Journal of Health Policy and Outcomes Research 2019;(1):10-6.

Lyman et al., 2018

Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, et al. American Society of Clinical Oncology statement: Biosimilars in oncology. J Clin Oncol 2018;36(12):1260-5

Martinez-Lopez de Castro et al., 2018

Martinez-Lopez de Castro N, Matilla-Fernandez MB, Fraga-Fuentes MD, Mangues-Bafalluy I, Asensi-Diez R, G. C-O. Spanish Society of Hospital Pharmacy position paper on biosimilar medicines. Farm Hosp 2018;42(4):180-3.

Moayyedi et al., 2020

Moayyedi P, Benchimol EI, Armstrong D, Yuan C, Fernandes A, Leontiadis GI. Joint Canadian Association of Gastroenterology and Crohn's Colitis Canada position statement on biosimilars for the treatment of inflammatory bowel disease. J Can Assoc Gastroenterol 2020;3(1):e1-e9.

Mularczyk et al., 2014

Mularczyk A, Gonciarz M, Bartnik W, Durlik M, Eder P, Gasiorowska A, et al. Biosimilar medicines – Their use in the treatment of inflammatory bowel diseases.

Position statement of the Working Group of the Polish National Consultant in Gastroenterology. Prz Gastroenterol 2014;9(1):1-3.

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Identification Référence Pathologie Molécule

Biologique Devis

Nakashima, 2019 Nakashima L. III-190 Oncology biosimilars utilization policy. Vancouver, BC : BC Cancer, Provincial Health Services Authority; 2019. Disponible à : http://shop.healthcarebc.ca/phsa/BCCancer/Systemic%20Therapy/70329.pdf.

NICE, 2016 National Institute for Health and Care Excellence (NICE). Biosimilar medicines. Londres, Angleterre : NICE; 2016. Disponible à : https://www.nice.org.uk/advice/ktt15/resources/biosimilar-medicines-pdf-58757954414533.

NRAS, 2019

National Rheumatoid Arthritis Society (NRAS). NRAS position paper on biosimilar medicines – Updated February, 2019. Maidenhead, Royaume-Uni : NRAS;

2019. Disponible à :

https://www.nras.org.uk/data/files/About%20RA/How%20is%20RA%20managed/NRAS%20revised%20position%20paper%20biosimilars%20Feb%202019.pdf.

Roediger et al., 2017

Roediger A, Freischem B, Reiland J-P. What pricing and reimbursement policies to use for off-patent biologicals in Europe? – Results from the second EBE biological medicines policy survey. Generics and Biosimilars Initiative Journal 2017;6(2):61-78.

SAMAC, 2017

South Australia Medicines Advisory Committee (SAMAC). Biosimilars - Guiding principles for the governance of biological and biosimilar medicines. Adelaïde, Australie : SA Health; 2017. Disponible à :

https://www.sahealth.sa.gov.au/wps/wcm/connect/02994280419bed2e8251badb31a1ff3d/Biosimilars_Guiding+principles+for+the+governance+of+biological+an d+biosimilar+medicines.pdf.

SCR, 2019 Société canadienne de rhumatologie (SCR). Énoncé de position de la Société canadienne de rhumatologie sur les biosimilaires [site Web]. Mississauga, ON : SCR; 2019. Disponible à : https://rheum.ca/fr/enonce-de-position-de-la-societe-canadienne-de-rhumatologie-sur-les-biosimilaires/ (consulté le 23 janvier 2020) Tabernero et al.,

2016

Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, et al. Biosimilars: A position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open 2016;1(6):e000142.

Wiek, 2018

Wiek D. Biosimilars – Position Paper: Updating position statement from the European League Against Rheumatism (EULAR) Standing Committee of People with Arthritis/Rheumatism in Europe (PARE). Zurich, Suisse : EULAR PARE; 2018. Disponible à :

https://www.eular.org/myUploadData/files/biosimilars_paper_updated_2018_09_14_dw.pdf.