The EMA is planning to launch a tailored biosimilar scientific advice pilot project from February 2017. The pilot will advise developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available (standard scientific advice does not include the assessment of existing data).
The project is open to all types of biosimilars and the EMA will take a maximum of one project a month. The project will run until it has completed six projects, after which the agency will analyse the outcomes of the pilot project.
For any information regarding the pilot please contact ScientificAdvice@ema.europa.eu