EMA guidelines for development of biosimilars [Guidelines EMA pour le développement de médicaments biosimilaires]

摘要

For the past ten years, innovative biological products have had an important impact in treating life-threatening and chronic diseases such as cancer. With the expiry of patent rights and data protection, the development and marketing of similar biological products (biosimilars) like Generics for small entities became reality in the European Union. Particularly in hematology and oncology, biosimilars have been developed, as reflected in the activities of the European Medicines Agency (EMA) in terms of scientific advice and marketing authorisation procedures. Since the creation of the European framework for biosimilar products, the Committee for Medicinal Products for Human Use (CHMP) together with the relevant multidisciplinary working parties at the EMA has been working to give patients access to high-quality biosimilar products by ensuring that the quality, efficacy and safety of these biosimilar products are similar to that of the reference biological product. In order to facilitate the development and availability of such medicines, the Agency has produced several guidelines explaining the general principles of the comparability exercise as well as product-specific requirements. The European framework has been evolving with the experience gained and the scientific progress has made the availability of high-quality biosimilarmedicines inmore andmore product classes for the benefit of patients in Europe.