News | January 18, 2024

Formycon Ranibizumab Biosimilar FYB201/CIMERLI Achieved A Market Share Of 38% In The United States In December 2023

Formycon AG today announced that its commercialization partner, Coherus BioSciences, Inc. has released new sales figures for CIMERLI (Ranibizumab-eqrn) in the US. Accordingly, the number of CIMERLI doses sold since its commercial launch in the US in October 2022 has increased to around 190,000 by the end of 2023. In October 2023, the number of doses sold was reported at 100,000. Thus, the amount almost doubled in the fourth quarter of 2023. According to Coherus, cumulative sales of CIMERLI in the US totaled USD 125 million, exceeding original expectations by around 25%. Formycon benefits from net sales in the low double-digit million range, which are reflected partly in sales and partly in the at-equity result of the 50% participation in Bioeq AG.

CIMERLI is the first FDA-approved Lucentis -biosimilar for both strengths. In December 2023, CIMERLI achieved a market share of 38% by volume in the US Ranibizumab market and thereby continues to be the most successful biosimilar in this segment.

„We are extremely pleased with the successful uptake of our Lucentis biosimilar in the US, which has continued to gain momentum from quarter to quarter. The figures are similarly positive in the UK, where FYB201 (trade name: Ongavia) achieved a market share of 69% in November 2023.6 This is confirmation of the outstanding quality of our biosimilar and the strong performance of our commercialization partners. With recent approvals in Canada, among others, and subsequent expected approvals and launches in Latin America, the Middle East and North Africa, we see how this highly important treatment option in the field of ophthalmology reaches more and more markets and can contribute to the best possible care for patients,“ 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. With FYB201 Formycon already has one biosimilar on the market. Five more are currently in development.

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.

Source: Formycon AG