Horus Pharma selected as additional commercialization partner for aflibercept biosimilar in Europe

(Image credit: AdobeStock/peopleimages.com)

Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon’s Eylea1 biosimilar FYB203 (aflibercept), issued an additional semi-exclusive license agreement with Horus Pharma for the commercialization of FYB203/Baiama 2 in selected European countries.¹

This agreement follows the semi-exclusive partnership signed in January with Teva Pharmaceuticals International GmbH for the commercialization of FYB203/AHZANTIVE 3 covering major parts of Europe and Israel.²

The press release¹ issued states that upon signature, Klinge is eligible to receive upfront and milestone payments, plus royalties on net sales. Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge resulting from these agreements. Furthermore, Formycon will act as 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.

Nicola Mikulcik, CBO of Formycon AG is quoted in the release¹ discussing the partnership with Horus Pharma: “We are very pleased that we could add Horus Pharma, a distinguished specialist in ophthalmology, to the group of our excellent commercial partners. Horus will market the brand Baiama in selected European markets including its home market France. Baiama will be sold as a second brand in addition to AHZANTIVE, which will be launched by Teva across Europe. Teva is already successfully marketing our Lucentis 4 biosimilar Ranivisio 5. With our 2-brand-partner strategy we are striving for the best possible therapeutic coverage to fully leverage the high market potential in Europe.”

Previously, Ophthalmology Times covered the exclusive license agreement with US biosimilars specialist, Valorum Biologics LLC, for commercialization of FYB203 (AHZANTIVE) in the US and Canada. The arrangement of royalties and milestone payments of the agreement with Valorum Biologics is similar to those presented in this agreement with Horus.²

Ophthalmology Times also covered the announcement of the approval of this biosimilar by the UK Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, 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 2024.²

Reference:

1. Horus Pharma becomes additional commercialization partner for Formycon’s Eylea biosimilar FYB203 in selected European countries under the brand name Baiama. Formycon AG. News Release. September 17, 2025. Accessed September 17, 2025. https://www.eqs-news.com/news/corporate/horus-pharma-becomes-additional-commercialization-partner-for-formycons-eylea-biosimilar-fyb203-in-selected-european-countries-under-the-brand-name-baiama/dcb8ddc0-86a9-48b1-89b9-2d9e2cfd7253_en

2. 2. 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-

3. 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