Posted by Michael Wonder on 18 Dec 2016
Tailored scientific advice to support step-by-step development of new biosimilars
16 December 2016 - Pilot project to commence in February 2017.
The 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.
This is expected to better support the stepwise development of biosimilars that is recommended in European Union guidelines. According to this approach, the extent and nature of the studies/tests required depend on the level and robustness of data already accumulated.
