The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) of a biosimilar version of Neulasta (pegfilgrastim) to treat chemotherapy-induced neutropenia from Cinfa Biotech.
Approval
The MAA for the biosimilar company’s lead product candidate B12019, has been supported by a comprehensive set of data from analytical, biofunctional and clinical studies, comparing the biosimilar to the reference drug Neulasta. The clinical development programme included two studies, confirming the analytical and biofunctional similarity of B12019 and Neulasta in highly sensitive clinical study settings, which was based on scientific advice from the EMA.
“We are pleased that the EMA has initiated the review of the Marketing Authorisation Application of B12019,” stated Dr Ruediger Jankowsky, managing director of Cinfa Biotech. “This is a major milestone in our endeavour to provide patients with high-quality and affordable treatment options. We are proud of having completed the development of B12019 in just four years. It confirms our highly efficient development approach.”
