Posted by Michael Wonder on 07 Oct 2017
European Medicines Agency accepts marketing authorisation application for Cinfa Biotech’s pegfilgrastim biosimilar B12019 for review
4 October 2017 - Cinfa Biotech today reported acceptance of the marketing authorisation application by the EMA for its lead development candidate B12019, a biosimilar version of Neulasta (pegfilgrastim) to treat chemotherapy-induced neutropenia.
The B12019 application is supported by a comprehensive set of biosimilarity data from analytical, biofunctional and clinical studies comparing B12019 and Neulasta. Based on scientific advice from EMA, the clinical development program included two studies, which confirmed the analytical and biofunctional similarity of B12019 and Neulasta in highly sensitive clinical study settings.
