EMA TO LAUNCH SCIENTIFIC ADVICE PILOT TO AID IN THE DEVELOPMENT OF NEW BIOSIMILARS

Biosimilar News  •  EMA News

The European Medicines Agency (EMA) is planning to launch a pilot project aimed at testing the value of tailored scientific advice for the development of biosimilar medicines. Based on the analysis of analytical and functional data provided by the applicants, the EMA will provide recommendations on which tests/studies should be completed in the next stage of development. These assessments should provide applicants with the ability to make more informed decisions regarding their biosimilar development strategy.

The pilot is available to all companies who wish to receive scientific advice on the development of biosimilar medicines. The pilot program will continue until six scientific inquiries have been completed. Once complete, the EMA will carry out an analysis of the outcome. The project is slated to begin in February 2017.

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