期刊
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
卷 82, 期 6, 页码 1444-1457出版社
WILEY
DOI: 10.1111/bcp.13076
关键词
biosimilar drug development programmes; biosimilarity; biosimilars; EMA; EPAR; trial design
资金
- Swiss State Secretariat for Education, Research and Innovation (SERI) [999754557]
- European Union's Horizon research and innovation programme under the Marie Sklodowska-Curie [633567]
- Austrian Science Fund [SFB54-P04]
AimIn 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. MethodsWe 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. ResultsThe variability between the clinical development strategies is high. Some differences are explainable by the characteristics of the product; if, for example, the PD marker can be assumed to predict the clinical outcome, no efficacy trials might be necessary. However, even for products with the same reference product, the sample size, endpoints and statistical models are not always the same. ConclusionsThere seems to be flexibility for sponsors regarding the decision as to how best to prove biosimilarity.
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