Munich – Today Bioeq IP AG, the exclusive owner of the global commercialization rights of Formycon’s biosimilar candidate to Lucentis®1 (FYB201), informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) that it has signed a license and development agreement with Coherus BioSciences, Inc. The US Biosimilar-specialist, headquartered in Redwood City, California, will exclusively market and distribute FYB201 in the United States of America (US). Bioeq plans to file the Biologics License Application with the U.S. Food and Drug Administration in the fourth quarter of 2019 and Coherus plans to launch the product in the United States in 2021. Formycon very much appreciates the decision and considers Coherus as a strong and competent partner for a successful commercialization of FYB201 in the US.
1)Lucentis® is a registered trademark of Genentech Inc.
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of antibody-based COVID-19 compounds.
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.