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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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Bibliografiska uppgifter
I publikationen:Br J Clin Pharmacol
Huvudupphovsmän: Mielke, Johanna, Jilma, Bernd, Koenig, Franz, Jones, Byron
Materialtyp: Artigo
Språk:Inglês
Publicerad: John Wiley and Sons Inc. 2016
Ämnen:
Länkar: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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