FYB203 Biosimilar Expands to U.S. and Canada with Valorum

Formycon AG has announced that Klinge Biopharma, the exclusive global commercialization rights holder of FYB203/AHZANTIVE (aflibercept-mrbb), Formycon’s biosimilar to Eylea, has entered into an exclusive license agreement with Valorum Biologics, a U.S.-based biosimilars specialist. Under the agreement, Valorum will commercialize FYB203/AHZANTIVE in the United States and Canada.

Financial Terms and Supply Chain Responsibilities

With the signing of the agreement, Klinge Biopharma becomes eligible to receive upfront and milestone payments, in addition to royalties on net sales. Formycon will participate in these revenue streams at a mid-single-digit to low-double-digit percentage.

Moreover, Formycon will serve as an authorized designee for organizing the commercial supply chain of FYB203/AHZANTIVE and will receive:

• Service payments

• A volume-based profit component tied to market supply coordination efforts on behalf of Klinge

Strategic Outlook: Strengthening Ophthalmic Biosimilars Portfolio

“Partnering with Valorum as a dedicated market specialist builds a key success component for the commercialization of FYB203/AHZANTIVE in the United States and Canada,” said Dr. Stefan Glombitza, CEO of Formycon. “Valorum’s experienced management team and deep understanding of U.S. market dynamics, combined with a strong customer network, makes them an ideal partner. This collaboration maximizes the potential of our second ophthalmic biosimilar and further strengthens our position as a leading biosimilar player.”

Commercial Commitment from Valorum Biologics

Par Hyare, CEO of Valorum Biologics, stated: “We are pleased to introduce AHZANTIVE in the United States 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.”

Industry Perspective: Biosimilars in the Evolving U.S. Healthcare Landscape

Wolfgang Essler, Chief Representative of ATHOS KG and Chairman of the Supervisory Board of Formycon, emphasized:
“Biosimilars will become even more a game-changer in the US health care 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 health care 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.”