U.S. biosimilar specialist Valorum Biologics LLC becomes commercialization partner for Formycon’s Eylea® biosimilar FYB203/AHZANTIVE® (aflibercept-mrbb) in the United States and Canada

Press Release // June 25, 2025
 

U.S. biosimilar specialist Valorum Biologics LLC becomes commercialization partner for Formycon’s Eylea^® biosimilar FYB203/AHZANTIVE^® (aflibercept-mrbb) in the United States and Canada
 

• Valorum Biologics, an expert for ophthalmology and oncology biosimilars in the U.S. market, will exclusively commercialize FYB203/AHZANTIVE^® in the United States and Canada
• Formycon’s major shareholder ATHOS KG directly supports the commercialization of FYB203/AHZANTIVE^® by leading the Series A financing of Valorum
   

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) today announces that Klinge Biopharma GmbH (Klinge), the exclusive owner of the global commercialization rights of FYB203/AHZANTIVE^®1 (aflibercept-mrbb), Formycon’s biosimilar to Eylea^®2, concluded an exclusive license agreement with U.S. biosimilars specialist Valorum Biologics LLC (“Valorum”) for the commercialization of FYB203/AHZANTIVE^® in the United States and Canada.

Upon signature of the agreement, Klinge is eligible to receive upfront payments 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 this agreement. Furthermore, Formycon will act as authorized designee to organize the supply chain for FYB203/AHZANTIVE^® and will receive additional service payments and a volume-based profit component for organizing the commercial market supply on behalf of Klinge.

Valorum is a biosimilar commercialization specialist established by experienced industry leaders including past presidents of AmerisourceBergen , Cardinal Health and General Manager of McKesson , respectively. The company is focused on best-in-class commercialization of biosimilars in the U.S. to improve access, reach and cost savings for the healthcare system. Valorum has built a team with unparalleled experience and established networks across the U.S. pharmaceutical market and will be well positioned to maximize the commercial potential of FYB203/AHZANTIVE^®. The team has collectively launched several multi-billion-dollar pharmaceutical products within large pharmaceutical organizations such as Johnson & Johnson , Merck KGaA and Roche in the past.

ATHOS KG³, a major indirect shareholder of Formycon, leading the Series A financing of Valorum underlines its confidence in this U.S. commercialization partner, their strategy and the potential of FYB203/AHZANTIVE^®.

“Partnering with Valorum as a dedicated market specialist builds a key success component for the commercialization of FYB203/AHZANTIVE^® in the U.S. and Canada. The highly experienced management team with profound knowledge of U.S. market dynamics along with a strong customer network makes Valorum a powerful choice to drive the commercialization of our second ophthalmic biosimilar product. We are delighted to join forces with this highly committed partner to maximize the - market potential of AHZANTIVE^® and further strengthen our strategic position as biosimilar player,” says Dr. Stefan Glombitza, CEO of Formycon AG.

Par Hyare, CEO of Valorum Biologics, added: “We are pleased to introduce AHZANTIVE^® in the U.S. and Canada, recognizing its strong potential as a biosimilar to Eylea^®. With our team’s proven expertise in specialty markets and established track record of commercial excellence, we are committed to driving broad market adoption, reinforcing our industry leadership, and helping reduce financial burdens for patients and providers alike.”

Wolfgang Essler, chief representative (Generalbevollmächtigter) of ATHOS KG and Chairman of the Supervisory Board of Formycon AG, commented: “Biosimilars will become even more a game-changer in the U.S. healthcare system. As the industry moves toward more sustainable healthcare models, biosimilars provide a unique opportunity to improve patient access to life-saving treatments while reducing the overall burden on the healthcare system. We believe in the great potential of Formycon’s high-quality biosimilar products and are convinced that the partnership with Valorum will set the course for additional commercial success.”

FYB203/AHZANTIVE^® obtained FDA approval for the treatment of patients with Age-related neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO) in June 2024. The active ingredient inhibits the vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina. Launch timing for FYB203/AHZANTIVE^® in the U.S. depends on several factors, like the progress and outcome of pending or potential future related litigations or any potential settlements. Approval of FYB203 by the Canadian regulatory authority Health Canada is expected by the end of this year.

¹  AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
²  Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
³  Through its subsidiary Santo Holding (Deutschland) GmbH, ATHOS KG represents an indirect shareholder of Formycon AG

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 and TecDAX selection indices. Further information can be found at: https://www.formycon.com/

About Valorum Biologics:
Valorum provides best-in-class execution for the regulatory approval, launch and commercialization of biosimilars in the U.S. The Valorum team brings unparalleled experience and established networks across the U.S. pharmaceutical market and is focused on optimizing commercialization in order to improve access, reach and cost savings for the healthcare system. Visit www.valorum.bio.

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.

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.