Cinfa Biotech S.L.

Cinfa Biotech S.L.

Sales markets: Western Europe | Eastern Europe | Middle East | Australia | North America

About us

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. An expert team specialised in biosimilars is conducting product development, clinical studies, manufacturing and quality control in Europe, according to the highest quality standards.

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.
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Meet us at

9 oct 2018

CPhI Worldwide 2018

9 - 11 October 2018 Madrid, Spain Visit us at stand 14.0G60 Book a meeting See our Exhibitor Profile

News about Cinfa Biotech S.L.

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

7 Feb 2018

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

Press Release - October 4, 2017

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7 Feb 2018

Cinfa Biotech begins US partnering and prepares US development for B12019, a proposed biosimilar to Neulasta® (pegfilgrastim)

Press Release - December 14, 2017

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Media

Downloads

Cinfa Biotech Flyer
catalog | 2018-03-27
B12019: Fact Sheet
catalog | 2018-03-27
B12019: POSTER ASH Annual Meeting 2017 Atlanta (Nov 24th 2017)

Comparability of Pharmacodynamics and Immunogenicity of B12019, a Proposed Pegfilgrastim Biosimilar to Neulasta®

catalog | 2018-03-27
B12019: POSTER ESMO Conference 2017 Madrid (Sept 10th 2017)

Pharmacokinetic and Pharmacodynamic Comparability of B12019, a Proposed Pegfilgrastim Biosimilar

catalog | 2018-03-27
B12019: POSTER ECCO Conference 2017 Amsterdam (Jan 23rd 2017)

Demonstration of Pharmacokinetic and Pharmacodynamic Comparability

in Healthy Volunteers for B12019, a Proposed Pegfilgrastim Biosimilar

catalog | 2018-03-27

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Cinfa Biotech S.L.

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