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

ABSTRACT:

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 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 features compared were, among others, the number of patients enrolled, the number of trials, the types of trial design, choice of endpoints and equivalence margins for pharmacokinetic (PK)/pharmacodynamic (PD) and phase III trials.

Results

The variability between the clinical development str

SUBMITTER: Mielke J 

PROVIDER: S-EPMC5099555 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature