Formycon announces FDA approval of FYB201/CIMERLITM1 (ranibizumab-eqrn) as a Biosimilar interchangeable with Lucentis®2

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces that the U.S. Food and Drug Administration (“FDA”) has approved CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection). FYB201 was developed by Bioeq AG, a Joint Venture between Formycon AG and Polpharma Biologics Group BV. End of the year 2019, Coherus BioSciences, Inc. (“Coherus”) entered into a license agreement for the exclusive commercialization of FYB201 under the brand name CIMERLI™ in the United States of America (“U.S.”). The commercial launch of CIMERLI™, in both 0.3mg and 0.5mg dosages, in the U.S. by Coherus, is planned for early October 2022. CIMERLI™ obtained approval from FDA for the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema following Retinal Vein Occlusion (RVO) and Myopic Choroidal Neovascularization (mCNV). CIMERLI™ is the first and only interchangeable biosimilar with an exclusivity for 12 month after market launch, that is indicated for the treatment of all five Lucentis® indications and as such is a new medical option for patients with serious retinal diseases. FDA-approval and interchangeability designation are based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. Efficacy, safety, pharmacokinetics and immunogenicity of CIMERLI™ were found to be comparable to the reference drug Lucentis® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD). 1) CIMERLI™ is a trademark of Coherus BioSciences, Inc. 2) Lucentis® is a registered trademark of Genentech Inc. 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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