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 biosimilar product candidate Pelmeg®, a biosimilar version of Neulasta® (pegfilgrastim), we have successfully proven this concept. Pelmeg® has received CHMP recommendation for marketing authorization in the EU in September 2018. The marketing authorization application is supported by a comprehensive set of biosimilarity data from analytical, biofunctional and clinical studies comparing Pelmeg® and Neulasta®.
Cinfa Biotech was created in 2013. With offices in Pamplona, Spain, and in Munich, Germany, at Cinfa Biotech we conduct biosimilars development and manufacturing exclusively in Europe. Highest European quality standards based on strict guidelines and our specialist know-how are the key to our success in the global biosimilars market.