Pilot to test benefit of tailored scientific advice on development of biosimilars

The European Medicines Agency (EMA) is planning to launch a pilot project in February 2017 to assess the viability and value of customised scientific advice for the development of biosimilars. The new approach will provide a more in-depth assessment of the data concerning development to date, focussing on quality, analytics and function. The EMA hopes that this stepwise approach will provide developers with more detail on the studies/tests they should be conducting based on the data they already have on the medicine. This additional information will allow them to make a more informed decision on the development strategy. However, in line with the usual principles for scientific advice, the new initiative does not constitute a formal pre-assessment of the data submitted during the marketing authorisation application. At PharmaLex we have considerable expertise in the development of biosimilars. If you are developing biosimilars for the EU or US and would like to discuss your requirements, please contact us on uk@pharmalex.com or call +44 (0)1628 530554.

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