FDA Approves Eylea Biosimilar Aflibercept-mrbb for Serious Retinal Diseases

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Aflibercept-mrbb showed comparable safety, efficacy, pharmacokinetics, and immunogenicity compared with the reference product.

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/
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