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The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019.
Biologicals. 2020 May;65:1-9. doi: 10.1016/j.biologicals.2020.02.005. Epub 2020 Mar 27.
Biologicals. 2020.
PMID: 32224101
Free PMC article.
Review.
WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.
Wadhwa M, Kang HN, Jivapaisarnpong T; WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products; Andalucia LR, Blades CDRZ, Casas Levano M, Chang W, Chew JY, Chilufya MB, Chirachanakul P, Cho HG, Cho YO, Choi KM, Chong S, Chua HM, Farahani AV, Gencoglu M, Ghobrial MRW, Guha P, Gutierrez Lugo MT, Ha SB, Habahbeh S, Hamel H, Hong Y, Iarutkin A, Jang H, Jayachandran R, Jivapaisarnpong T, Kang HN, Kim DY, Kim GH, Kim Y, Kwon HS, Larsen J, Lee AH, Lee J, Medvedeva K, Munkombwe Z, Oh I, Park J, Park J, Putri DE, Rodgers J, Ryu S, Savkina M, Schreitmueller T, Semeniuk O, Seo M, Shin YI, Shin J, Srivastava S, Song H, Song S, Tavares Neto J, Wadhwa M, Yamaguchi T, Youn HD, Yun M.
Wadhwa M, et al. Among authors: ghobrial mrw.
Biologicals. 2020 May;65:50-59. doi: 10.1016/j.biologicals.2019.12.008. Epub 2020 Jan 17.
Biologicals. 2020.
PMID: 31959504
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