The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019-Reference-Cited by-同舟云学术

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

Published:2020-05 Issue: Volume:65 Page:1-9
ISSN:1045-1056
Container-title:Biologicals
language:en
Short-container-title:Biologicals

Author:

Kang Hye-Na,Thorpe Robin,Knezevic Ivana,Blades Carolina Damas Rocha Zarate,Casas Levano Mary,Chew Jing Yin,Chilufya Mumbi Bernice,Chirachanakul Parichard,Chua Hui Ming,Farahani Ali Vasheghani,Ghobrial Mariam Raouf Wefky,Habahbeh Suna,Hamel Hugo,Kim Gi Hyun,Perez Rodriguez Violeta,Putri Desi Eka,Rodgers Jacqueline,Savkina Maria,Semeniuk Oleh,Srivastava Shraddha,Wadhwa Meenu,Yamaguchi Teruhide

Funder

The Ministry of Health and Welfare, Republic of Korea

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference17 articles.

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3. Statistical considerations for confirmatory clinical trials for similar biotherapeutic products;Njue;Biologicals,2011

5. The role of the quality assessment in the determination of overall biosimilarity: a simulated case study exercise;Schiestl;Biologicals,2014

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