Cinfa Biotech S.L.
Cinfa Biotech’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 clinical 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. Comparative analytical and functional data are currently being generated for B12019 regarding EU-authorised and US-licensed reference product. A briefing package for FDA will be compiled with these data.
We are looking for commercialisation and marketing partnerships for our high quality biosimilar medicines. In particular we are interested in out-licensing and co-development opportunities for North America. We have the structure, flexibility and entrepreneurial know-how to develop solutions tailored to the needs of our partners and customised for their markets.
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Our lead product candidate B12019 is a biosimilar version of Neulasta® (INN: pegfilgrastim) to treat chemotherapy-induced neutropenia. Pegfilgrastim, a granulocyte colony-stimulating factor (G-CSF) receptor agonist, is used to stimulate bone marrow to produce more neutrophils in order to decrease the inci...More info
News about Cinfa Biotech S.L.
7 Feb 2018
European Medicines Agency accepts Marketing Authorisation Application for Cinfa Biotech’s pegfilgrastim biosimilar B12019 for review
Press Release - October 4, 2017Read more
Comparability of Pharmacodynamics and Immunogenicity of B12019, a Proposed Pegfilgrastim Biosimilar to Neulasta®
Pharmacokinetic and Pharmacodynamic Comparability of B12019, a Proposed Pegfilgrastim Biosimilar
Demonstration of Pharmacokinetic and Pharmacodynamic Comparability
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