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Clinical trials for authorized biosimilars in the European Union: a systematic review

AIM: In 2006, Omnitrope (by Sandoz) was the first approved biosimilar in Europe. To date, 21 biosimilars for seven different biologics are on the market. The present study compared the clinical trials undertaken to obtain market authorization. METHODS: We summarized the findings of a comprehensive r...

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Publicat a:Br J Clin Pharmacol
Autors principals: Mielke, Johanna, Jilma, Bernd, Koenig, Franz, Jones, Byron
Format: Artigo
Idioma:Inglês
Publicat: John Wiley and Sons Inc. 2016
Matèries:
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC5099555/
https://ncbi.nlm.nih.gov/pubmed/27580073
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.13076
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