FDA Approves Eylea Biosimilar Aflibercept-mrbb for Serious Retinal Diseases

Credit: The US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved the aflibercept (Eylea) biosimilar aflibercept-mrbb (Ahzantive) for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD), according to a statement from Formycon AG and its licensing partner Klinge Biopharma GmbH.¹ The drug is also approved for other serious retinal diseases including diabetic macular edema (DME), macular edema following retinal vein occlusion (RVO), and diabetic retinopathy.

“The FDA approval of FYB203/Ahzantive is another key milestone on our way to becoming the leading pure-play biosimilar developer. It highlights the expertise and experience of our team,” Stefan Glombitza, PhD, CEO of Formycon AG said in a statement.¹

The biosimilar works by inhibiting the vascular endothelial growth factor (VEGF), a signal protein responsible for producing excessive blood vessels in the retina. Reference aflipercept is currently the best-selling anti-VEGF therapy, with global sales reaching approximately $9 billion in 2023.¹

The approval was based on a data package that included pre-clinical, clinical, analytical, and manufacturing data. Aflibercept-mrbb showed comparable safety, efficacy, pharmacokinetics, and immunogenicity compared with the reference product among a cohort of patients with nAMD.¹

“With the Eylea biosimilar FYB203/Ahzantive and our already approved Lucentis biosimilar FYB201, we have achieved an outstanding position in ophthalmic biosimilar therapies,” Glombitza stated.¹ “We are thus improving healthcare for patients with retinal diseases by offering effective, safe and, above all, affordable treatment options.”

Formycon AG also submitted a marketing authorization application for the biosimilar to the European Medicines Agency (EMA) at the end of 2023, with a decision expected by early 2025.¹

References

1. ^{Formycon receives FDA approval for FYB203/Ahzantive®) (aflibercept-mrbb), a biosimilar to Eylea®). News release. Formycon. July 1, 2024. Accessed July 1, 2024. https://www.formycon.com/en/blog/press-release/formycon-receives-fda-approval-for-fyb203-ahzantive/}