EQS-News: Actor Pharmaceuticals and Megalabs become partners for the commercialization of Formycon’s Eylea® biosimilar FYB203 (aflibercept) for Australia and Latin America

Press Release // October 16, 2025
 

Actor Pharmaceuticals and Megalabs become partners for the commercialization of Formycon’s Eylea^® biosimilar FYB203 (aflibercept) for Australia and Latin America
 

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announces that Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon's Eylea^®1 biosimilar FYB203 (aflibercept), concluded an exclusive license agreement with Actor Pharmaceuticals Pty. Ltd. (“Actor”) for the commercialization of FYB203 in Australia. Furthermore, for Latin America, Klinge has signed an exclusive license agreement with Megalabs S.A. (“Megalabs”).

Upon signature of the agreements, Klinge is eligible to receive upfront and milestone payments, plus royalties on net sales. Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge resulting from these agreements. Furthermore, Formycon will act as authorized designee to organize the supply chain for FYB203 and will receive additional service payments and a volume-based profit component for organizing the commercial market supply^{on behalf of Klinge.}

“Severe retinopathies are on the rise worldwide due to demographic trends and the increasing number of diabetes cases, which can lead to retinal diseases. With the partnerships for Australia and Latin America, Klinge has laid the foundation for making our Eylea^® biosimilar FYB203 available as an effective and cost-efficient treatment option in further important regions of the world. With Actor and Megalabs, we have gained two strong distribution partners with excellent regional networks and a profound local market knowledge. Together, we are focused on improving the treatment options for the many patients who have been underserved in the past. At the same time, we are contributing to reduce the financial burden on healthcare systems,” says Nicola Mikulcik, Chief Business Officer (CBO) of Formycon AG.

Actor Pharmaceuticals is an established Australian pharmaceutical company specializing in the registration and commercialisation of innovative medicines and biosimilars in Australia. With a strong commitment to quality, patient access, and long-term partnerships, Actor Pharmaceuticals collaborates with global industry leaders to bring clinically proven therapies to the Australian market. The company’s expertise spans product registration, market access, and commercialization - driving growth across both prescription and over-the-counter segments.

Megalabs is a leading pharmaceutical company based in Uruguay with a strong presence and market position in the Americas. Megalabs is at the cutting edge of biotechnological innovation, with its High-Tech business unit serving as one of the main pillars of the organization’s success. The company's various business areas also include the development, manufacturing and marketing of biosimilar products.

In June 2024, the aflibercept biosimilar FYB203 was approved by the US Food and Drug Administration (“FDA”). Approval by the European Commission followed in January 2025 and approval by the British MHRA one month later. For Australia, the regulatory application has been submitted to the Therapeutic Goods Administration (“TGA”). Formycon is also working closely with Megalabs to prepare the applications for approval in Latin American countries.²

Eylea^® (aflibercept) is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The active ingredient inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

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¹⁾  Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

²⁾  The commercial launch of FYB203 in Australia and Latin America depends on several factors – firstly on approval by the respective regional regulatory authorities, and secondly on the progress and outcome of ongoing or potential future patent litigation or possible settlement agreements.

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. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline 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 selection index. 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 Actor Pharmaceuticals:
Actor Pharmaceuticals is a privately held pharmaceutical company dedicated to improving access to high-quality, clinically proven healthcare products across Australia and New Zealand. With a focus on trusted European brands, innovation, and patient well-being, Actor partners with global manufacturers to introduce and grow consumer and prescription health solutions in the region. Backed by deep industry expertise and a long-term vision, Actor Pharmaceuticals is committed to building enduring brands that make a meaningful difference in people’s lives.

About Megalabs:
Megalabs is a pharmaceutical company committed to providing healthcare professionals and consumers with affordable therapeutic solutions for a healthier and more fulfilling life. The company is present in 20 countries, with more than 8,000 collaborators, and offers more than 1,800 products that span all therapeutic areas. Its continuous growth is supported by 18 production plants, a highly diversified portfolio with more than 1,800 products, and 12 R&D centers. Megalabs is a forward-looking company with an established reputation as one of the leading pharmaceutical players in the Americas.

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

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.