Valorum Biologics to commercialize Formycon’s Eylea Biosimilar FYB203 in US and Canada

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Formycon has announced Klinge Biopharma GmbH, exclusive owner of the global commercialization rights of FYB203 (AHZANTIVE), concluded an exclusive license agreement with US biosimilars specialist Valorum Biologics LLC for commercialization in the US and Canada.

FYB203 is Formycon’s biosimilar to Eylea, and like its reference product, the biosimilar is an anti-vascular endothelial growth factor (VEGF) agent used to treat retinal disease. Chief among those indications is neovascular age-related macular degeneration (AMD), also known as wet AMD.

At the beginning of 2025, it was announced that Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd, would partner with Klinge and Formycon in commercializing FYB203 in designated regions of Europe, excluding Italy, and in Israel.²

Upon signature of the new agreement, Klinge is eligible to receive upfront payments and milestone payments, as well as royalties on net sales. According to Formycon, the company will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge resulting from the agreement. Formycon will also act as an 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.

Stefan Glombitza, PhD, CEO of Formycon AG, commented on the partnership in a press release from the company, saying, “Partnering with Valorum as a dedicated market specialist builds a key success component for the commercialization of FYB203/AHZANTIVE in the US 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.”

The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved FYB203 for the treatment of neovascular age-related macular degeneration (nAMD), diabetic macular edema, macular edema following retinal vein occlusion, and visual impairment due to myopic choroidal neovascularization in February 2025.³ The US Food and Drug Administration (FDA) had previously approved the biosimilar in July 2024.⁴

The company stated that commercial launch in the US is dependent on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements. Furthermore, the company noted that approval of FYB203 by the Canadian regulatory authority Health Canada is expected by the end of 2025.

References:

1. US biosimilar specialist Valorum Biologics LLC becomes commercialization partner for Formycon’s Eylea biosimilar FYB203/AHZANTIVE® (aflibercept-mrbb) in the United States and Canada. Published June 25, 2025. Accessed June 25, 2025. https://www.eqs-news.com/news/corporate/u-s-biosimilar-specialist-valorum-biologics-llc-becomes-commercialization-partner-for-formycons-eylea-biosimilar-fyb203-ahzantive-aflibercept-mrbb-in-the-united-states-and-cana/cb3ede06-c5b8-4d5b-a19e-a9a8d6d28893_en

2. Hayes H. Formycon partners with Teva, Klinge Biopharma for commercialization of aflibercept biosimilar FYB203 (AHZANTIVE). Published January 13, 2025. Accessed June 25, 2025. https://www.ophthalmologytimes.com/view/formycon-partners-with-teva-klinge-biopharma-for-commercialization-of-aflibercept-biosimilar-fyb203-ahzantive-

3. Hayes H. UK MHRA issues approval for aflibercept biosimilar FYB203 (AHZANTIVE) from Formycon. Published February 25, 2025. Accessed June 25, 2025. https://www.ophthalmologytimes.com/view/uk-mhra-issues-approval-for-aflibercept-biosimilar-fyb203-ahzantive-from-formycon

4. Harp MD. FDA approves Formycon’s biosimilar to Eylea, aflibercept-mrbb (Ahzantive). Published July 2, 2024. Accessed June 25, 2025. https://www.ophthalmologytimes.com/view/fda-approves-formycon-s-biosimilar-to-eylea-aflibercept-mrbb-ahzantive-