EMA initiative for tailored scientific advice for the development of new biosimilars

The European Medicines Agency (EMA) will commence a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development of biosimilar medicines. EMA aims to provide developers of biosimilars with advice on the studies and tests they should be performing, on the basis of the quality, analytical and functional data already available for the medicine. This should assist with the stepwise development of biosimilars that is recommended in EU guidelines.

The standard scientific advice procedure advises applicants on the proposed development strategy, but the procedure does not include a formal assessment of data. As part of this pilot, an in-depth review of the quality, analytical and functional data available will be performed. Advice will be given on the data submitted thereby delivering specific recommendations on the studies and tests that should be carried out in the next step of the drug’s development. This will allow companies to make a more informed decision on the development strategy once sufficient quality data has been generated. However, it should be noted that this will not constitute a formal pre-assessment of the data.

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

The pilot will run until six scientific advice requests have been completed, after which the EMA will analyse the results.

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