EMA’s Scientific Advice Pilot on Biosimilars

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] EMA released a Q&A regarding a pilot project to be launched 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 which studies and tests would be required by the applicants. The extent and nature of the required studies will depend on the level and robustness of data already available for the medicine. This pilot is expected to support the step-wise development of biosimilars currently recommended in European Union (EU) guidelines. EMA’s more general scientific advice program to assist companies involved in developing medicines can be found here. [See IPQ’s Oct./Nov. 2016 Monthly Update for a review of biosimilar regulatory developments in the US.]
[/membership]