CHMP Issues Positive Opinion for FYB203, a Biosimilar Candidate to Aflibercept

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the marketing authorization of FYB203, a biosimilar candidate to aflibercept. This development marks a significant milestone in expanding affordable treatment options for retinal diseases.

Key Insights from Formycon and Klinge Biopharma

In a joint press release, Dr. Stefan Glombitza, CEO of Formycon AG, expressed enthusiasm about the CHMP’s decision. He stated:

“We are excited about the positive CHMP opinion for FYB203, our biosimilar candidate to Eylea. As our second ophthalmic biosimilar therapy following the success of our Lucentis biosimilar, FYB203 represents a further advancement in treatment options for serious retinal diseases. After FDA approval in June, this milestone is a testament to the expertise, dedication, and hard work of the entire Formycon team and underscores our commitment to enhancing patient care through affordable alternatives. We are now awaiting European Commission approval in the second half of January 2025 and look forward to offering patients a high-quality treatment option that can improve their quality of life.”

FYB203: Indications and Clinical Potential

FYB203 has been recommended by CHMP for the treatment of serious retinal diseases in adult patients, including:

       • Age-related Neovascular Macular Degeneration (nAMD)

       • Diabetic Macular Edema (DME)

       • Visual Impairment due to Myopic Choroidal Neovascularization (CNV)

       • Macular Edema Following Retinal Vein Occlusion (RVO)

The biosimilar has demonstrated potential to expand access to essential therapies for these conditions, offering a cost-effective alternative to existing treatments.

CHMP Opinion: A Step Towards European Approval

The CHMP’s recommendation represents a critical regulatory step towards FYB203’s approval in Europe. Once approved, the product will be marketed under the trade names AHZANTIVE and Baiama within the European Union.

The CHMP’s scientific assessment report is central to the European Commission’s decision-making process. The European Commission is expected to grant marketing authorization in the second half of January 2025. This approval would be valid across all European Economic Area (EEA) countries, including the 27 EU Member States, Iceland, Liechtenstein, and Norway.

FDA Approval Achieved in 2024

FYB203 previously received approval from the US Food and Drug Administration (FDA) in June 2024, further validating its safety and efficacy. The FDA’s endorsement set a precedent for the biosimilar’s potential impact on global ophthalmic care.

Conclusion

The CHMP’s positive opinion for FYB203 signifies a major step forward in addressing unmet needs in retinal disease management. Pending European Commission approval, FYB203 is poised to provide patients across Europe with a high-quality and affordable treatment option, enhancing their quality of life.