Valorum Biologics LLC, a U.S. biosimilar commercialization specialist, has entered into an exclusive licensing agreement with Klinge Biopharma GmbH to commercialize FYB203/AHZANTIVE® (aflibercept-mrbb), Formycon's biosimilar to Eylea®, across the United States and Canada. The partnership represents a strategic move to bring the FDA-approved ophthalmology treatment to North American markets.
Financial Structure and Revenue Sharing
Under the agreement terms, Klinge Biopharma is eligible to receive upfront payments, milestone payments, and royalties on net sales. Formycon AG will participate in the mid-single-digit to low-double-digit percentage range across all payment streams flowing to Klinge from this commercialization deal. Additionally, Formycon will serve as the authorized designee to organize the supply chain for FYB203/AHZANTIVE® and will receive supplementary service payments plus a volume-based profit component for managing commercial market supply operations.
Regulatory Status and Therapeutic Applications
FYB203/AHZANTIVE® received FDA approval in June 2024 for treating patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases, including diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO). The biosimilar's active ingredient inhibits vascular endothelial growth factor (VEGF), which is responsible for excessive blood vessel formation in the retina.
The biosimilar has also secured regulatory approval from the European Medicines Agency (EMA) in January 2025 and the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2025. Canadian regulatory approval from Health Canada is anticipated by the end of 2024.
Commercial Strategy and Market Positioning
Valorum Biologics brings specialized expertise in ophthalmology and oncology biosimilars to the U.S. market. The company was established by experienced industry leaders, including former presidents of AmerisourceBergen and Cardinal Health, as well as a former General Manager of McKesson. The management team has collectively launched several multi-billion-dollar pharmaceutical products within major organizations such as Johnson & Johnson, Merck, and Roche.
"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," said Dr. Stefan Glombitza, CEO of Formycon AG. "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."
Strategic Investment and Market Outlook
ATHOS KG, a major indirect shareholder of Formycon, is leading the Series A financing of Valorum, demonstrating confidence in the commercialization strategy and the biosimilar's market potential. Wolfgang Essler, chief representative of ATHOS KG and Chairman of the Supervisory Board of Formycon AG, emphasized the transformative role of biosimilars in the U.S. healthcare system.
"Biosimilars will become even more a game-changer in the U.S. healthcare system," Essler commented. "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."
Launch Timeline and Market Considerations
The launch timing for FYB203/AHZANTIVE® in the U.S. market depends on several factors, including the progress and outcome of pending or potential future related litigation or any potential settlements. Par Hyare, CEO of Valorum Biologics, expressed commitment to driving broad market adoption while helping reduce financial burdens for patients and healthcare providers.
The global biosimilars market, currently valued at approximately $21 billion, is projected to exceed $74 billion by 2030, according to industry analysts. By 2032, many biopharmaceutical drugs will lose patent protection, including 45 blockbusters with an estimated total annual global turnover exceeding $200 billion, creating significant opportunities for biosimilar market entry.
