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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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Detalles Bibliográficos
Autores principales: Mielke, Johanna, Jilma, Bernd, Koenig, Franz, Jones, Byron
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5099555/
https://www.ncbi.nlm.nih.gov/pubmed/27580073
http://dx.doi.org/10.1111/bcp.13076