Formycon Ranibizumab Biosimilar FYB201/Cimerli ¹ Achieved 25% Market Share² In The United States

Formycons commercialization partner Coherus BioSciences, Inc. announced that sales of CIMERLI (ranibizumab-eqrn) to retinal specialists in the United States of America (“U.S.”) have exceeded 100,000 doses since commercial launch on October 3, 2022.

CIMERLI is the first and only FDA-approved biosimilar interchangeable with Lucentis3 for both strengths. In August 2023, CIMERLI achieved 25% market share of the ranibizumab market, making it the number one ranibizumab biosimilar in the United States (“U.S.”).

“This is a great achievement and underlines again that biosimilars are an important treatment option for severe retinal diseases. With FYB20¹, we have developed an excellent product, which has now become number one ranibizumab biosimilar in the U.S. market. We are also fully on track with our next two late-stage assets. File Acceptance by the U.S. Food and Drug Administration (“FDA”) for FYB20³ (Eylea⁴ biosimilar candidate) has already been reported and submission to the European Medicines Agency (“EMA”) is also planned in the course of this year. The same applies for FYB20² (Stelara⁵ biosimilar candidate) which has already been accepted by the EMA and is fully on schedule regarding FDA submission,” commented Dr. Stefan Glombitza, CEO of Formycon AG.

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 six 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 drug FYB207.

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 2025, 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. Currently, global sales of biosimilars are estimated at more than $15B. By 2030, analysts estimate that this figure could rise to over $74B.