FORMYCON AND BIOEQ ANNOUNCE SUBMISSION OF THE BIOLOGICS LICENSE APPLICATION (BLA) FOR FYB201, A BIOSIMILAR CANDIDATE TO LUCENTIS(R)1 (RANIBIZUMAB) TO THE U.S. FOOD AND DRUG ADMINISTRATION (FD
Munich ? Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (?Bioeq?) announce that the biologics license application (BLA) for FYB201, Formycon?s biosimilar candidate to Lucentis(R), has been recently submitted to the U.S. Food and Drug Administration (FDA).
Lucentis(R) is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.
If approved, Coherus BioSciences, Inc. (?Coherus?) will commercialize FYB201 (also known as CHS-201) in the United States of America per the terms of the November 2019 license and development agreement between Bioeq and Coherus. Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and the Str?ngmann Group and develops, licenses and commercializes biosimilars. Coherus is a U.S. pharmaceutical company with an expertise in biosimilar development and commercialization.
1)Lucentis(R)?is a registered trademark of Genentech Inc.
About Formycon:
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 a COVID-19 fusion protein.
About Biosimilars:
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.
Press & IR Contact
Sabrina M?ller
Senior Manager Corporate Communications and
Investor Relations
T + 49 89 86 46 67 149
F + 49 89 86 46 67 110
sabrina.mueller@formycon.com