Developing a pegfilgrastim biosimilar to increase patient access to cancer care

In just four years, Cinfa Biotech’s pegfilgrastim biosimilar has been developed, been tested, and received acceptance from the European Medicines Agency for review of a marketing authorization application to treat neutropenia.

Like Comment
Page of
Go to the profile of CINFA


Cinfa Biotech is headquartered in Pamplona, Spain, with offices in Munich, Germany. The Company develops, manufactures and commercialises high-quality biosimilars for oncology and inflammatory diseases to address the growing need for affordable therapies. The company’s lead product candidate is B12019, a biosimilar version of Neulasta® (pegfilgrastim) used to treat chemotherapy-induced neutropenia. The Marketing Authorisation Application for B12019 for the European Union was accepted for review by the EMA in September 2017, the review is in progress. The clinical development program was based on scientific advice from EMA and included two studies, which confirmed the analytical and biofunctional similarity of B12019 and Neulasta® in highly sensitive clinical study settings. A GMP manufacturing process for B12019 has been established at commercial scale. Recently, the company started partnering activities and the preparation of development in the US.

No comments yet.