Regulatory challenges with biosimilars: an update from 20 countries-Reference-Cited by-同舟云学术

Regulatory challenges with biosimilars: an update from 20 countries

Published:2020-11-21 Issue:1 Volume:1491 Page:42-59
ISSN:0077-8923
Container-title:Annals of the New York Academy of Sciences
language:en
Short-container-title:Ann. N.Y. Acad. Sci.

Author:

Kang Hye‐Na¹,Thorpe Robin²,Knezevic Ivana¹,Casas Levano Mary³,Chilufya Mumbi Bernice⁴,Chirachanakul Parichard⁵,Chua Hui Ming⁶,Dalili Dina⁷,Foo Freddie⁸,Gao Kai⁹,Habahbeh Suna¹⁰,Hamel Hugo¹¹,Kim Gi Hyun¹²,Perez Rodriguez Violeta¹³,Putri Desi Eka¹⁴,Rodgers Jacqueline¹⁵,Savkina Maria¹⁶,Semeniuk Oleh¹⁷,Srivastava Shraddha¹⁸,Tavares Neto João¹⁹,Wadhwa Meenu²⁰,Yamaguchi Teruhide²¹

Affiliation:

1. Department of Health Product Policy and Standards World Health Organization Geneva Switzerland

2. Independent Expert Welwyn United Kingdom

3. General Directorate of Medicines Supplies and Drugs (DIGEMID) San Miguel Peru

4. Zambia Medicines Regulatory Authority Lusaka Zambia

5. Food and Drug Administration Nonthaburi Thailand

6. National Pharmaceutical Regulatory Agency Selangor Malaysia

7. Iran Food and Drug Administration Tehran Iran

8. Health Sciences Authority Singapore

9. Shanghai University Shanghai People's Republic of China

10. Jordan Food and Drug Administration Amman Jordan

11. Health Canada Ottawa Ontario Canada

12. Ministry of Food and Drug Safety Osong‐eup Republic of Korea

13. Centro para el Control Estatal de Medicamentos Equipos y Dispositivos Médicos (CECMED) La Habana Cuba

14. The Indonesian Food and Drug Authority Jakarta Indonesia

15. Food and Drugs Authority Accra Ghana

16. The Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health Moscow Russian Federation

17. Ministry of Health of Ukraine Kyiv Ukraine

18. Central Drug Standards Control Organization (CDSCO) Ministry of Health & Family Welfare New Delhi India

19. Brazilian Health Regulatory Agency (ANVISA) Brasilia Brazil

20. National Institute for Biological Standards and Control, Medicines and Healthcare products Regulatory Agency Potters Bar United Kingdom

21. Pharmaceuticals and Medical Devices Agency Tokyo Japan

Publisher

Wiley

Subject

History and Philosophy of Science,General Biochemistry, Genetics and Molecular Biology,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/nyas.14522

Reference24 articles.

1. WHO Expert Committee on Biological Standardization.2013.Annex 2. Guidelines on evaluation of similar biotherapeutic products (SBPs). WHO Technical Report Series no. 977. Accessed August 19 2020.http://who.int/biologicals/publications/trs/areas/biological_therapeutics/TRS_977_Annex_2.pdf.

2. The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019

3. Rodgers J. H.‐N.Kang I.Knezevic et al.2015.Meeting Report. First WHO implementation workshop on regulatory evaluation of biotherapeutics including biosimilars in the African region Accra Ghana 8–10 September 2015. Accessed August 19 2020.https://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_Ghana_WS_report_HK_18_Feb_2016.pdf?ua=1.

4. Regulatory evaluation of biosimilars throughout their product life-cycle

5. Quality assessment and its impact on clinical performance of a biosimilar erythropoietin: A simulated case study

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