We are committed to high-quality, urgently needed biosimilars for oncology and inflammatory diseases. Our products will broaden access to biopharmaceuticals, allowing more patients to benefit from scientific advances.
A deep understanding of protein-based therapeutics enables us to conduct efficient biosimilar development programs. They are based on current scientific, regulatory and healthcare market considerations. On the basis of our efficient approach, we are able to develop biosimilars in a manageable and foreseeable time period.
For our first product candidate, a biosimilar version of Neulasta® (pegfilgrastim), we have successfully proven this concept. The development has been successfully finalised, demonstrating high similarity to the originator product in analytical, biofunctional and clinical studies. The Marketing Authorisation Application (MAA) for the European Union has been submitted and accepted for review by the EMA in 2017.
Cinfa Biotech was created in 2013 as part of the Spanish Cinfa Group.
With headquarters in Pamplona, Spain, and offices in Munich, Germany, at Cinfa Biotech we conduct biosimilars development and manufacturing exclusively in Europe. Highest European quality standards based on strict guidlines and our specialist know-how are the key to our success in the global biosimilars market.