Formycon's Eylea Biosimilar FYB203 Approved in EU

Formycon, in collaboration with its licensing partner Klinge Biopharma, has announced that the European Commission has granted central marketing authorization for FYB203 (aflibercept), a biosimilar to Eylea. The product will be marketed under the brand names Ahzantive and Baiama.

Approved Indications

The approval covers the treatment of several retinal conditions, including:

• Wet Age-Related Macular Degeneration (nAMD)

• Diabetic Macular Edema (DME)

• Visual Impairment due to Myopic Choroidal Neovascularisation (CNV)

• Macular Edema Following Retinal Vein Occlusion (RVO)

Scope of Approval

This decision by the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in November 2024. The authorization applies to all countries within the European Economic Area (EEA), including:

• The 27 EU member states

• Iceland

• Liechtenstein

• Norway

Leadership Perspective

Dr. Stefan Glombitza, CEO of Formycon AG, highlighted the significance of the approval:

“The EU approval of FYB203, our biosimilar for Eylea®, marks another milestone for Formycon and is based on the expertise and dedication of our entire team. As our second ophthalmic biosimilar, FYB203 significantly expands therapeutic options for patients with severe retinal diseases. With AHZANTIVE® and Baiama®, we are improving access to high-quality and affordable therapies that contribute sustainably to enhancing patients’ quality of life.”

Commercialization and Licensing Agreements

In January 2025, Formycon and Teva Pharmaceuticals International entered into a licensing agreement for the semi-exclusive commercialization of FYB203 in major parts of Europe and Israel. Additionally, Formycon has finalized a product supply agreement with Teva to support this rollout.

Regulatory Milestones

FYB203 had previously received FDA approval in June 2024, marking a significant step forward in its global availability for patients requiring biosimilar treatments.

Looking Ahead

The EU approval of FYB203 strengthens Formycon’s position in the biosimilar market and expands access to cost-effective treatment options for retinal diseases across Europe and beyond. With partnerships in place and regulatory milestones achieved, Formycon continues its commitment to improving patients’ quality of life through innovative, affordable therapies.