HPE Viatris Handbook | Page 14

TABLE 2
Examples of regulatory agencies and guidelines for biosimilar approvals ( adapted from 4 )
Country Regulatory body Adopted from / aligned with Relevant regulation
European Union
European Medicines Agency ( EMA )
Committee for Human Medicinal Products ( CHMP ) International Council for Harmonization ( ICH )
EMA 2005 9 CHMP 2014 13
United States
Canada
Australia
Japan
Food and Drug Administration ( FDA )
Health Canada , Biologics and Genetic Therapies Directorate
Therapeutic Goods Administration
Pharmaceuticals and Medical Devices Agency ( PMDA )
10 , 11
USFDA USFDA 2015 , 2019
EMA , USFDA , WHO Canada 2010 14
EMA TGA 2018 15
EMA Japan 2009 16
South Korea Ministry of Food and Drug Safety EMA , WHO South Korea 2022 17
India
China
Argentina
Brazil
Central Drugs Standard Control Organization and the Review Committee on Genetic Manipulation
China National Drug Administration ( CNDA )
Administracion Nacional de Medicamentos , Alimentos y Tecnologia Medica ( ANMAT )
Agencia National de Vigilancia Sanitaria ( ANVISA )
EMA , USFDA India 2016 18
19 , 20
EMA , USFDA CNDA 2014
EMA ANMAT legislation no 7729 ( 2011 ) 21
WHO ANVISA Resolution no . 55 / 2010 22
References 1 European Medicines Agency . Biosimilar medicines : Overview . www . ema . europa . eu / en / human-regulatory / overview / biosimilar-medicines-overview ( accessed Feb 2023 ). 2 European Medicines Agency and the European Commission . Biosimilars in the EU - Information Guide for healthcare professionals . 2019 www . ema . europa . eu / en / documents / leaflet / biosimilars-eu-information-guidehealthcare-professionals _ en . pdf ( accessed Feb 2023 ). 3 European Medicines Agency . Biosimilar medicines : marketing authorization . www . ema . europa . eu / en / humanregulatory / marketing-authorisation / biosimilar-medicines-marketingauthorisation ( accessed Feb 2023 ). 4 Nupur N et al . Analytical similarity assessment of biosimilars : Global regulatory landscape , recent studies and major advancements in orthogonal platforms . Front Bioeng Biotechnol 2022 ; 10:832059 . 5 European Medicines Agency . Immunogenicity assessment of biotechnology-derived therapeutic proteins . EMEA / CHMP / BMWP / 14327 / 2006 . www . ema . europa . eu / docs / en _ GB / document _
library / Scientific _ guideline / 2009 / 09 / WC500003946 . pdf ( accessed Feb 2023 ). 6 European Medicines Agency . Guideline on good pharmacovigilance practices ( GVP ), Product- or Population-Specific Considerations II : Biological medicinal products . EMA / 168402 / 2014 . http :// www . ema . europa . eu / docs / en _ GB / document _ library / Scientific _ guideline / 2016 / 08 / WC500211728 . pdf ( accessed Feb 2023 ). 7 EMA Medicines : European Medicines Agency . 2020 . www . ema . europa . eu / en / medicines / search _ api _ aggregation _ ema _ medicine _ types / field _ ema _ med _ biosimilar ( accessed Feb 2023 ). 8 World Health Organization . Final Expert Committee on Biological Standardization : Guidelines on Evaluation of Similar Biotherapeutic Products ( SBPs ). 2009 9 EMA . ICH Topic Q5E : Comparability of Biotechnological / Biological Products . 2005 . www . ema . europa . eu / en / documents / scientific-guideline / ich-q- 5-e-comparability-biotechnological / biological-products-step-5 _ en . pdf ( accessed Feb 2023 ). 10 WHO . Expert Committee on Biological Standardization : Guidelines on Evaluation of Monoclonal Antibodies as Similar Biotherapeutic Products ( SBPs ) - Annex 2 . 2013 .
11 US FDA . Guidance for Industry : Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product . 2015 https :// www . fda . gov / media / 82647 / download ( accessed Feb 2023 ). 12 US FDA . Draft Guidance : Development of Therapeutic Protein Biosimilars : Comparative Analytical Assessment and Other Quality-Related Considerations . 2019 13 Committee for Medicinal Products for Human Use . Committee for Medicinal Products for Human Use ( CHMP ): Guideline on Similar Biological Medicinal Products - Revision 1 . 2014 . www . ema . europa . eu / en / documents / scientificguideline / guideline-similar-biologicalmedicinal-products-rev1 _ en . pdf ( accessed Feb 2023 ). 14 Government of Canada . Guidance document : Information and submission requirements for biosimilar biologic drugs . www . canada . ca / en / healthcanada / services / drugs-health-products / biologics-radiopharmaceuticals-genetictherapies / applications-submissions / guidance-documents / informationsubmission-requirements-biosimilarbiologic-drugs-1 . html # int ( accessed Feb 2023 ). 15 TGA . Biosimilar Medicines Regulation :
Therapeutic Goods Administration : Version 2.2 . www . tga . gov . au / publication / biosimilar-medicines-regulation ( accessed Feb 2023 ). 16 PMDA . List of Approved Products : Pharmaceuticals and Medical Devices Agency . 2020 . www . pmda . go . jp / english / review-services / reviews / approvedinformation / drugs / 0002 . html ( accessed Feb 2023 ). 17 MFDS . Biosimilar : Ministry of Food and Drug Safety . www . mfds . go . kr / eng / brd / m _ 27 / view . do ? seq = 70199 ( accessed Feb 2023 ). 18 DBT . CDSCO : Guidelines on Similar Biologics : Regulatory Requirements for Marketing Authorization in India . https :// org . iisc . ac . in / wp-content / uploads / 2020 / 11 / Guidelines-on-Similar- Biologics . pdf ( accessed Feb 2023 ). 19 Regulation of copy biologicals in China . GaBI J 2018 ; 7 ( 2 ): 75 – 6 . 20 Chinese guidelines for copy biologicals . www . gabionline . net / guidelines / Chinese-guidelines-for-copybiologicals ( accessed Feb 2023 ). 21 ANMAT . www . anmat . gov . ar / webanmat / retiros / noviembre / Disposicion _ 7729-2011 . pdf 22 ANVISA . https :// bvsms . saude . gov . br / bvs / saudelegis / anvisa / 2010 / res0055 _ 16 _ 12 _ 2010 . html
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