FDA approves biosimilar Eylea Aflibercept-mrbb for serious retinal diseases

The U.S. Food and Drug Administration (FDA) has approved a biosimilar of aflibercept (Eylea) and aflibercept-mrbb (Ahzantive) for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD), according to a statement from Formycon AG and its licensing partner Klinge Biopharma GmbH.¹ The drug is also approved to treat 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 milestone on our path to becoming a leading pure-play biosimilar company. It highlights the expertise and experience of our team,” Stefan Glombitza, Ph.D., CEO of Formycon AG, said in a statement.¹

Biosimilar works by inhibiting vascular endothelial growth factor (VEGF), a signaling protein responsible for the production of excessive blood vessels in the retina. Reference aflipercept is currently the best-selling anti-VEGF therapy, with global sales expected to reach about $9 billion in 2023.¹

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

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

In late 2023, Formycon AG also submitted an application for marketing authorisation for a biosimilar to the European Medicines Agency (EMA), and a decision is expected in early 2025.¹

Bibliography

1. ^{Formycon Receives FDA Approval for FYB203/Ahzantive®) (aflibercept-mrbb), a biosimilar to Eylea®). Press release. Formycon. July 1, 2024. Accessed July 1, 2024.}