EQS-News: Formycon receives regulatory approval in the UK for FYB203 (aflibercept), a biosimilar to Eylea®, under the brand name AHZANTIVE®

Press Release // February 25, 2025
 

Formycon receives regulatory approval in the UK for FYB203 (aflibercept), a biosimilar to Eylea^®, under the brand name AHZANTIVE^®

• FYB203 (aflibercept) approved in the UK for the treatment of neovascular age-related macular degeneration (nAMD) and several other severe retinal diseases
• UK market authorization follows successful regulatory approvals by the FDA and the European Commission for FYB203
• Teva Pharmaceuticals will market FYB203 / AHZANTIVE^® in major parts of Europe, including the United Kingdom

Planegg-Martinsried, Germany - Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its licensing partner Klinge Biopharma GmbH (Klinge) jointly announce that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB203 (aflibercept), a biosimilar to Eylea^®1, under the brand name AHZANTIVE^®2. The approval covers the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal conditions, including Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO).

“With the approval of FYB203, our second ophthalmic biosimilar in the UK, we take yet another significant step in making essential ophthalmic therapies more widely available,” said Dr. Stefan Glombitza, CEO of Formycon AG. “In addition to Ongavia^®3, our successful ranibizumab biosimilar in the UK, AHZANTIVE^® will provide a new, cost-efficient treatment option for patients with severe retinal diseases, through our strong commercial partner Teva.”

The U.S. Food and Drug Administration (FDA) had already granted marketing authorization for FYB203 in June 2024, followed by European Commission`s approval in January 2025.

Recently, Formycon and Teva Pharmaceuticals International GmbH (Teva) announced a partnership for the semi-exclusive commercialization of FYB203 across major parts of Europe, including the United Kingdom, and Israel. Concurrently, Formycon had concluded an agreement with Teva for product supply. Teva is already marketing Formycon’s FYB201 ranibizumab Biosimilar (Ongavia^®) in the UK and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field.

Aflibercept is an inhibitor of the vascular endothelial growth factor (VEGF), which plays a key role in the abnormal formation of blood vessels in the retina, leading to vision impairment.

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¹⁾ Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
²⁾ AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
³⁾ Ongavia^® is a registered trademark of Teva Pharmaceuticals Limited

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. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, have 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 is headquartered in Munich, 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 systems. 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.

About Teva:
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader, harnessing its 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 58 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.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 - 86 46 67 149
Fax: + 49 (0) 89 - 86 46 67 110
Mail: Sabrina.Mueller@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.