Breadth and depth of established data will determine study approach.
In February 2017, the European Medicines Agency (EMA) plans to test the added value and feasibility of tailored scientific advice for the development of biosimilar medicines.
The pilot is open to all companies seeking scientific advice for the development of a biosimilar medicine, and planned to run until six scientific advice requests have been completed, with maximum one scientific advice request accepted per month, per the EMA's public statement. The objective of the pilot is to give developers of biosimilars advice for conducting studies/tests based upon qualitative, analytical, and functional data already available for the product, and to support the recommended biosimilars development within European Union (EU) guidelines.
Per the EMA, any type of biosimilar will be accepted in the pilot.
Companies that would like 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.