Formycon AG has secured two major commercialization partnerships for its aflibercept biosimilar FYB203 (AHZANTIVE), expanding global access to a cost-effective alternative to Eylea, one of the world's highest-revenue anti-VEGF therapies. The agreements with Teva Pharmaceuticals and Lotus Pharmaceutical establish comprehensive distribution networks across Europe, Israel, and eight Asia-Pacific countries.
Teva Partnership Strengthens European Market Position
Teva Pharmaceuticals International GmbH obtained semi-exclusive commercialization rights for FYB203 across major European markets, excluding Italy, as well as Israel. The licensing agreement, facilitated through Klinge Biopharma GmbH, builds upon Teva's existing commercial infrastructure for Formycon's ranibizumab biosimilar (Ranivisio/Ongavia) in the ophthalmology sector.
"With Teva, we are gaining a strong and proven partner for FYB203 in the major parts of Europe and Israel," commented Nicola Mikulcik, Chief Business Officer of Formycon AG. "Teva is already marketing our FYB201 ranibizumab biosimilar in Europe and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field."
Under the agreement, Klinge will receive milestone payments and royalties on net sales, while Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams. Notably, Formycon will assume responsibility for managing the entire commercial supply chain of the finished product for the first time.
Asia-Pacific Expansion Through Lotus Partnership
Simultaneously, Lotus Pharmaceutical secured exclusive licensing rights for FYB203 commercialization across eight Asia-Pacific countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam, and Hong Kong. The multinational pharmaceutical company brings established regional expertise and a diverse portfolio spanning novel, generic, and biosimilar medicines.
"Lotus is proud to partner with Formycon and to add AHZANTIVE (aflibercept), a biosimilar to Eylea, to our product portfolio aimed at improving access to healthcare in the Asia-Pacific region," stated Petar Vazharov, CEO of Lotus Pharmaceutical. The partnership includes upfront payments, milestone payments, and royalties on net sales, with Formycon participating in all Klinge income streams.
Regulatory Milestones and Market Opportunity
FYB203 received FDA approval in June 2024, followed by European Commission approval in January 2025 after a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use in November 2024. Formycon and Lotus are now preparing regulatory submissions for Asia-Pacific markets according to local requirements.
The biosimilar targets a substantial market opportunity, as Eylea (aflibercept) achieved global sales of approximately $9 billion in 2023, including $2.9 billion in the European market. The drug treats neovascular age-related macular degeneration and other severe retinal diseases by inhibiting vascular endothelial growth factor (VEGF), which causes excessive blood vessel formation in the retina.
Strategic Commercial Infrastructure
Both partnerships leverage existing commercial capabilities to accelerate market penetration. Teva's established distribution network in European ophthalmology markets provides immediate access to healthcare providers, while Lotus's regional presence across Asia-Pacific offers specialized knowledge of local regulatory requirements and market dynamics.
Richard Daniell, Executive Vice President European Commercial of Teva, emphasized the strategic value: "The collaboration expands Teva's broad biosimilar portfolio and again demonstrates our firm commitment to creating greater access to quality innovative medicines to the benefit of patients and the healthcare systems we serve."
The partnerships position FYB203 to capture market share as patent exclusivity expires for blockbuster biologics. Industry analysts project global biosimilar sales could rise from the current $21 billion to over $74 billion by 2030, driven by the loss of patent protection for 45 blockbuster drugs with combined annual sales exceeding $200 billion by 2032.
