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Statistical considerations in biosimilar assessment using biosimilarity index

When an innovative biologic product goes off patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. Unlike small molecule drug products, biosimilars are not exact copies of their brand-name counterpart, and they are usually ver...

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Detalhes bibliográficos
Main Authors: Zhang, Aijing, Tzeng, Jung-Ying, Chow, Shein-Chung
Formato: Artigo
Idioma:Inglês
Publicado em: 2012
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3967514/
https://ncbi.nlm.nih.gov/pubmed/24683298
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.4172/jbb.1000160
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