Abstract
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.
Highlights
Biologics have revolutionized treatment in important disease areas, such as cancer, diabetes and inflammatory diseases
Some restrictions were stated when considering the active substances epoetin alfa and epoetin zeta, which are both types of erythropoietin; for Silapo/Retacrit, the indication of ‘reduction in allogeneic blood transfusions in adult non-iron-deficient patients prior to major elective orthopaedic surgery’ was not granted owing to the lack of shown equivalence for the subcutaneous (SC) administration route
The present literature review of the European public assessment reports (EPARs) published by the European Medicines Agency (EMA) and additional publications related to clinical trials shows that there is a large variability between the submitted applications
Summary
Biologics have revolutionized treatment in important disease areas, such as cancer, diabetes and inflammatory diseases. The downside of the use of biologics is the high cost; in 2002, $46 billion were spent on biologics worldwide and it is expected that this will increase to $221 billion in 2017 [5]. Due to the high prices and the first expiry of patents of biologics over the last few years, the development of copies of biologics, so-called biosimilars, has recently gained much attention. The European Medicines Agency (EMA) is the leading regulator in this regard, having approved the first biosimilar in 2006 (Omnitrope, by Sandoz), and since the landscape of authorized biosimilars in Europe has widened considerably. It is predicted that the use of biosimilars may lead to a $250 billion reduction in spending on biologics in the US between 2014 and 2024 [6]
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