Press Release // January 18, 2024

Formycon Ranibizumab Biosimilar FYB201/CIMERLI^® achieved a market share of 38% in the United States in December 2023
 

Munich, Germany – Formycon AG (FWB: FYB) today announced that its commercialization partner, Coherus BioSciences, Inc. has released new sales figures for CIMERLI^®1 (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%.² 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^®3-biosimilar for both strengths. In December 2023, CIMERLI^® achieved a market share of 38% by volume in the US Ranibizumab market⁴ 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^®5) 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.

¹⁾CIMERLI^® is a registered Trademark of Coherus BioSciences, Inc.
²⁾Preliminary, unreviewed and unaudited financial information of Coherus BioSciences, Inc.
³⁾ Lucentis^® is a registered Trademark of Genentech Inc.
⁴⁾ IQVIA WSP & NSP 
⁵⁾Ongavia^® is a registered trademark of Teva Pharmaceutical Industries Ltd.
⁶⁾IQVIA Monthly Data

About Formycon:
Formycon (Frankfurt Stock Exchange: FYB / 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 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 USD 15 billion. By 2030, analysts estimate that this figure could rise to over USD 74 billion. 

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
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 Formycon’s 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.