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An update on the clinical evidence that supports biosimilar approvals in Europe

AIM: Sponsors and regulators have more than 10 years of experience with the development of biosimilars in Europe. However, the regulatory pathway is still evolving. The present article provides an update on biosimilar development in practice by reviewing the clinical development programmes of recent...

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Publicat a:Br J Clin Pharmacol
Autors principals: Mielke, Johanna, Jilma, Bernd, Jones, Byron, Koenig, Franz
Format: Artigo
Idioma:Inglês
Publicat: John Wiley and Sons Inc. 2018
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Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC6005614/
https://ncbi.nlm.nih.gov/pubmed/29575017
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.13586
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