European Medicines Agency accepts Marketing Authorisation Application for Cinfa Biotech’s pegfilgrastim biosimilar B12019 for review

Pamplona, Spain, 04 October 2017
Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today reported acceptance of the Marketing Authorisation Application (MAA) by the European Medicines Agency (EMA) for its lead development candidate B12019, a biosimilar version of Neulasta(R) (pegfilgrastim) to treat chemotherapy-induced neutropenia.

The B12019 MAA is supported by a comprehensive set of biosimilarity data from analytical, biofunctional and clinical studies comparing B12019 and Neulasta(R). Based on scientific advice from EMA, the clinical development program included two studies, which confirmed the analytical and biofunctional similarity of B12019 and Neulasta(R) in highly sensitive clinical study settings.

Dr Ruediger Jankowsky, Managing Director of Cinfa Biotech, commented:
We are pleased that the EMA has initiated the review of the Marketing Authorisation Application of B12019. 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.”

Recently, Cinfa Biotech presented the clinical development program of B12019 at the European Society for Medical Oncology (ESMO) Congress 2017. A poster abstract is available at

About Cinfa Biotech
Cinfa Biotech is headquartered in Pamplona, Spain, with offices in Munich, Germany. Founded in 2013 and supported by its parent company Cinfa Group, the Company is creating a pipeline of biosimilar drugs for a range of indications to address the growing need for affordable therapies based on proven science, quality, safety and efficacy. A complete team of experts with decades of in-depth experience is conducting product development, clinical studies, manufacturing and quality control, according to the highest European standards. Cinfa Biotech’s first product candidate is B12019, a biosimilar version of Neulasta(R) (pegfilgrastim). The commercialisation models will be customised to the needs of partners and markets.

With 50 years’ experience, Cinfa Group today employs over 1,800 people and reinvests an average of 90% of its annual profits in its portfolio companies, thereby driving their development and innovation. Cinfa Group’s first subsidiary, Laboratorios Cinfa, has become a recognised leader in the Spanish pharmaceutical market. As part of the internationalization strategy, the company also serves in currently over 50 countries and is further expanding.

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