Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) accepted the biologics license application (BLA) for FYB201, a biosimilar candidate to Lucentis®1, for review and assigned a target action date for the application for August 2022. Bioeq submitted the BLA to the FDA in August 2021.

Bioeq is a Swiss biopharmaceutical joint venture between the Struengmann Group and the Polpharma Biologics Group which develops, licenses and commercializes biosimilars.

Subject to regulatory approval, FYB201 (also known as BQ201 and CHS-201) will be commercialized in the United States of America by Coherus BioSciences, Inc. (“Coherus”), a US pharmaceutical company with an expertise in biosimilar development and commercialization. Formycon will participate economically in U.S. product sales through its interest in royalties paid by Coherus to Bioeq.

Lucentis® is used in the treatment of neovascular (wet) macular degeneration. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. This leads to progressive loss of vision and is one of the major causes of age-related blindness. The total market for ophthalmic drugs in anti-VEGF therapy is over $11 billion per year and, according to analysts, will continue to grow significantly.

1)Lucentis(R) is a registered trademark of Genentech Inc.