Formycon and Horus Partner on FYB203 in Europe

Formycon has announced an expanded commercialization pathway for its aflibercept biosimilar FYB203 through a new semi-exclusive licensing agreement between Klinge Biopharma and Horus Pharma. The product, to be marketed as Baiama, will be introduced in select European markets as part of a multi-brand strategy alongside Ahzantive, the brand launched by Teva Pharmaceuticals.

Horus Pharma to Commercialize Baiama in Select European Markets

Under the new agreement, Horus Pharma, a French-based ophthalmology-focused pharmaceutical company, will gain the right to commercialize Baiama in specific European countries, including France. This expands the footprint of FYB203 in Europe and complements Teva’s commercialization of the product as Ahzantive across most of Europe and Israel, following a January 2025 licensing agreement with Klinge Biopharma.

“We are very pleased to add Horus Pharma, a distinguished specialist in ophthalmology, to our network of commercial partners," said Nicola Mikulcik, Chief Business Officer at Formycon.

“With Baiama marketed alongside Ahzantive, we can achieve the best possible therapeutic coverage and fully leverage the high market potential in Europe.”

Financial Terms and Strategic Structure

While specific financial terms of the Horus agreement have not been disclosed, Klinge Biopharma is set to receive upfront and milestone payments, as well as royalties on net sales.

Formycon will participate in all payment streams, receiving a revenue share in the mid–single-digit to low–double-digit percentage range. Additionally, Formycon will act as Klinge’s authorized designee for supply chain management of FYB203, generating service payments and a volume-based profit component.

Dual-Brand Strategy: Baiama and Ahzantive

This agreement supports a two-brand commercial model, where both Teva and Horus market the same biosimilar therapy under different trade names:

• Ahzantive – marketed by Teva Pharmaceuticals

• Baiama – marketed by Horus Pharma

This strategic approach aims to maximize therapeutic coverage and market penetration across Europe by leveraging the unique distribution and market strengths of each partner.

Regulatory Milestones for FYB203 (Aflibercept Biosimilar)

FYB203 has already achieved significant regulatory progress, with U.S. FDA approval granted in June 2024, followed by European Commission authorization in January 2025 under the brand names Ahzantive and Baiama, and marketing authorization from the UK MHRA in February 2025.