Abstract:
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In 2006, Omnitrope (by Sandoz) was the first approved biosimilar in Europe. To date, twenty biosimilars for seven different biologics are on the market. In this presentation we summarize the findings of a comprehensive review of all clinical trials of authorised biosimilars using the European public assessment reports (EPAR) published by the European Medicines Agency (EMA). The compared features were, among others, number of patients involved, number of trials, study designs, endpoints and equivalence margins of both pharmacokinetic (PK)/pharmacodynamics (PD) and phase III trials. It was found that 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. Therefore, there seems to be flexibility for sponsors regarding the decision as how to best prove biosimilarity.
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