Cinfa Biotech S.L.
Cinfa Biotech’s lead product candidate is B12019, a biosimilar version of Neulasta® (pegfilgrastim) used 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 incidence of infection in patients undergoing chemotherapy.
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. The Marketing Authorisation Application for B12019 for the European Union is currently under review by EMA. Interactions with the FDA are being prepared to agree on the data package required for FDA licensing of B12019.
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 the US and Canada. We have the structure, flexibility and entrepreneurial know-how to develop solutions tailored to the needs of our partners and customised for their markets.
Meet us at
Our Top products
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
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation