Clinical trials for authorized biosimilars in the European Union: a systematic review.
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ABSTRACT:
SUBMITTER: Mielke J
PROVIDER: S-EPMC5099555 | biostudies-literature | 2016 Dec
REPOSITORIES: biostudies-literature
Publications
Clinical trials for authorized biosimilars in the European Union: a systematic review.
Mielke Johanna J Jilma Bernd B Koenig Franz F Jones Byron B
British journal of clinical pharmacology 20160905 6
<h4>Aim</h4>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.<h4>Methods</h4>We summarized the findings of a comprehensive review of all clinical trials up to market authorization of approved biosimilars, using the European public assessment reports (EPARs) published by the European Medicines Agency (EMA). The ...[more]
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