United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) grants Marketing Authorization for FYB201, Formycon's Biosimilar for Lucentis®¹, to be Commercialized by Teva as ONGAVIA®

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce, that today the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization (MA) in the United Kingdom (“UK”) for FYB201, a biosimilar to Lucentis® (ranibizumab). Teva Pharmaceutical Industries Ltd. (“Teva”) will serve as the exclusive commercial partner and will market the biosimilar under the brand name ONGAVIA® throughout the UK. Lucentis® is used in the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases like visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV). It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. The MHRA approval is based on a totality of evidence including analytical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study, the efficacy, safety, pharmacokinetics and immunogenicity of FYB201/ONGAVIA® was proven comparable to the reference drug Lucentis® (ranibizumab) in patients with age-related neovascular (wet) macular degeneration (nAMD). Dr. Stefan Glombitza, COO of Formycon comments: “Retinal diseases are an increasing burden for patients worldwide. We are pleased to announce the approval of our Lucentis® biosimilar in UK, creating a treatment option for some of the most common and serious retinal diseases.” The commercial launch of FYB201/ONGAVIA® in the UK by Teva Pharmaceutical Industries Ltd. (“Teva”), which has licensed the distribution rights from Bioeq under an exclusive strategic partnership, is expected to follow as soon as possible and targets to be the first available Biosimilar for Lucentis® in Europe. 1) 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, Formycon already has a biosimilar on the market in Europe and the USA. Another five 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 is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/en About Bioeq: Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group BV and Formycon AG. Bioeq develops, licenses and commercializes biosimilars. Bioeq is marketing authorization holder of Ranivisio® in Switzerland. www.bioeq.ch About Teva: Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery and expanded development of modern medicine. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 60 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.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 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. Press & IR Contact Sabrina Müller Director Investor Relations & 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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