Scientific Advice to Support Step-by-Step Development of 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 path of biosimilar medicines. Through this new initiative, 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 medicine. Biosimilars are biological medicines developed to be highly similar to another biological medicine already authorised in the EU. The pilot is open to all companies seeking scientific advice for the development of a biosimilar medicine.

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