Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea® (Aflibercept)

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge”) announce that the European Medicines Agency (“EMA”) has accepted the marketing authorization application (“MAA”) for FYB203, a biosimilar candidate to Eylea® 1 (Active Ingredient: Aflibercept), for review. Aflibercept is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases. Around 67 million people in Europe are affected by AMD [ [i] ] . Due to current demographic trends, this number is expected to continue to rise in the coming years. In most cases, intravitreal injections with the VEGF inhibitor Aflibercept can significantly slow down or even stop the loss of vision caused by the neovascular form of AMD. “The experience of recent years shows that both patients and healthcare systems benefit from biosimilar competition. With the recent EMA acceptance for our ophthalmological biosimilar candidate FYB203, we are an important step closer to providing another effective treatment option – in addition to our already launched biosimilar FYB201 (ranibizumab) – to the many patients affected by severe retinal diseases in Europe”, says Formycon CEO Dr. Stefan Glombitza. —– 1 Eylea ® is a registered Trademark of Regeneron Pharmaceuticals Inc. [i] Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis; Li JQ, Welchowski T, Schmid M, et al. British Journal of Ophthalmology 2020;104:1077-1084. http://dx.doi.org/10.1136/bjophthalmol-2019-314422 About Formycon: Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market in Europe and the USA. A third biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA; FYB202 is also approved in Canada. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG, headquartered in Munich, is listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX and TecDAX selection indices. Further information can be found at: https://www.formycon.com/ About Biosimilars: Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare providers. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030. 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. Press & IR Contact Sabrina Müller Director Investor Relations and Corporate Communications T + 49 89 86 46 67 149 F + 49 89 86 46 67 110 [email protected] Formycon AG Fraunhoferstr. 15 82152 Planegg/Martinsried Germany www.formycon.com

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