EMA Reveals Initiative on New Biosimilars

The European Medicines Agency (EMA) will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development of biosimilar medicines.

The EMA aims to provide developers of biosimilars with advice on the studies/tests they should be conducting, on the basis of the quality, analytical, and functional data they have already available for the product. This is designed to boost support the stepwise development of biosimilars that is recommended in European Union (EU) guidelines.

Biosimilars are biological medicines developed to be highly similar to another biological medicine (also known as the reference medicine) already authorized in the EU, according to an EMA statement. To obtain a marketing authorization, developers must establish similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety and efficacy.

The pilot is open to all companies seeking scientific advice for the development of a biosimilar medicine. Any type of biosimilar will be accepted in the pilot, noted the EMA. Companies wishing to take part in the pilot will have a pre-submission meeting during which the suitability of the data package is reviewed. The EMA’s Scientific Advice Working Party will need an extra month in addition to normal scientific advice timelines to review the requests accepted in the pilot.

The pilot is planned to run until six scientific advice requests have been completed, with maximum one scientific advice request accepted per month, the statement concluded.

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