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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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Détails bibliographiques
Publié dans:Br J Clin Pharmacol
Auteurs principaux: Mielke, Johanna, Jilma, Bernd, Jones, Byron, Koenig, Franz
Format: Artigo
Langue:Inglês
Publié: John Wiley and Sons Inc. 2018
Sujets:
Accès en ligne: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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