News | October 8, 2021

Formycon And Bioeq Announce File Acceptance For Fyb201, A Biosimilar Candidate To Lucentis (Ranibizumab) By The U.S. Food And Drug Administration (FDA)

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 Lucentis1, 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 $11B per year and, according to analysts, will continue to grow significantly.

1 Lucentis 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 an innovative COVID-19 drug.

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. Global sales of biosimilars are estimated to exceed $15B by 2020. By 2030, analysts estimate that this figure could rise to over $60B.

Source: Formycon