Search

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. In this paper, the clinical trials undertaken to get market authorisation are compared. Methods We summarize the findings of a comprehensive review of all clinical trials up to market authorisation 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)/pharmacodynamics (PD) and Phase III trials. Results The 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. But even for products with the same reference product, the sample size, the endpoints and the statistical models are not always the same. Conclusions There seems to be flexibility for sponsors regarding the decision as how to best prove biosimilarity. This article is protected by copyright. All rights reserved.