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Company

Cinfa Biotech is the biosimilars company of Cinfa Group, a pharmaceutical leader in Spain with more than 50 years of experience, offering a broad portfolio of business lines. We develop, manufacture and commercialise high-quality biosimilars for oncology and inflammatory diseases.

With our headquarters in Pamplona, Spain and offices in Munich, Germany we are committed to highest European quality standards. This forms the basis for addressing the global biosimilars market.

We do our business on a fully integrated level. We cover the entire pharmaceutical value chain from the manufacturing process development to clinical studies; and from regulatory strategy to commercialisation.

Our in-depth technical, clinical, regulatory and commercial expertise and highest European standards ensure the quality of our products. Highly efficient structures in our development and manufacturing processes enable us to quickly progress on our way to market.

Products

Cinfa Biotech is developing highest-quality biosimilars for indications in oncology and inflammatory diseases.

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 incidence of infection in patients undergoing chemotherapy.

The development program for B12019 has been successfully finalised. A GMP manufacturing process has been established at commercial scale. B12019 provides a high level of comparability to Neulasta in physico-chemical and biofunctional parameters. The clinical development program for B12019 was based on scientific advice from EMA and included two clinical studies. Both studies were finalised successfully and demonstrated comparability of B12019 to Neulasta in pharmacokinetics, pharmacodynamics, safety and immunogenicity.

The Marketing Authorisation Application (MAA) for the European Union was accepted for review by the EMA.

Partnering

We are interested in commercialisation and marketing partnerships for our highest quality biosimilars. Following our culture of expertise and cooperation, we welcome great ideas that have the potential to enhance patient access and create business options. We have the structure, flexibility and entrepreneurial spirit to develop solutions tailored to the needs of our partners and customised for their markets.

We look forward to a lively exchange of ideas with you!

Career

Are you ready to shape the future of biosimilars? Become part of our innovative expert team!

Our products are created in an unconventionally pleasant working environment. That’s why we are looking for experts who are also renowned for their skills: team players and passionate creators who appreciate working together in an atmosphere of mutual trust and candidness.

If you want to become part of our team in Munich (Germany) please send us your application.

We look forward to meeting you!

CMC Project Manager (m/f)

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Manager Regulatory Affairs CMC (m/f)

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Contact

Cinfa Biotech S.L.

Travesía de Roncesvalles, 1
E-31699 Olloki (Navarra)
Spain

Contact

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