Formycon and Bioeq announce submission of the biologics license application (BLA) for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the U.S. Food and Drug Administration (FDA)

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 Strüngmann 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.