Press Release // October 10, 2023

Formycon Ranibizumab Biosimilar FYB201/CIMERLI®¹ achieved 25% market share² in the United States

Munich – 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 Lucentis®³ for both strengths. In August 2023, CIMERLI® achieved 25% market share of the ranibizumab market, making it the number one ranibizumab biosimilar in the 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 (Eylea®⁴ 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 (Stelara®⁵ 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.

¹⁾CIMERLI® is a registered Trademark of Coherus BioSciences, Inc.

²⁾ IQVIA NSP Data August 2023

³⁾ Lucentis® is a registered Trademark of Genentech Inc.

⁴⁾Eylea® is a registered Trademark of Regeneron Pharmaceuticals Inc.

⁵⁾Stelara® is a registered Trademark of Johnson & Johnson

About Formycon:
Formycon (ISIN: DE000A1EWVY8 / WKN: A1EWVY) 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.

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 $15 billion. By 2030, analysts estimate that this figure could rise to over $74 billion.

Contact:
Sabrina Müller
Senior Manager Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com
 

Disclaimer:
This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.