US FDA approves biosimilar aflibercept-mrbb (Ahzantive)

In addition to Ahzantive, two other aflibercept biosimilars were recently approved by the FDA. Image credit: ©H_Ko – stock.adobe.com

The US Food and Drug Administration (FDA) announced it has approved aflibercept-mrbb (Ahzantive), biosimilar to Eylea, for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD). The news was announced in a press release from biosimilar developer Formycon AG and its licensing partner Klinge Biopharma, both based in Germany.¹

The biosimilar has also been approved for treatment in patients with serious retinal diseases such as diabetic macular oedema (DME), diabetic retinopathy (DR) and macular oedema following retinal vein occlusion (RVO).

In addition to Ahzantive, two other aflibercept biosimilars were recently approved by the FDA: Biocon Biologics's aflibercept-jbvf (Yesafili) and Samsung Bioepis aflibercept-yszy (Opuviz).

In the press release,¹ Formycon CEO Stefan Glombitza, PhD, stated that the FDA approval of Ahzantive was “another key milestone on [their] way to becoming the leading pure-play biosimilar developer. It highlights the expertise and experience of [their] team.” He further stated that, alongside Formycon's approved biosimilar FYB201 (reference drug Lucentis), he believes the company has an “outstanding position in ophthalmic biosimilar therapies.”

According to Formycon, the active ingredient in Ahzantive inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

The company said that the FDA approval was rooted in the company's “comprehensive data package” that included “analytical, pre-clinical, clinical and manufacturing data.” The data showed that Ahzantive demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Eylea in patients with nAMD.

In addition to the FDA approval, the company also submitted a marketing authorisation application with the European Medicines Agency (EMA) and expects a response by early 2025.

References:

1. Formycon Receives FDA Approval for FYB203/AHZANTIVE (AFLIBERCEPT-MRBB), a biosimilar to Eylea. Press Release. Published 1July, 2024. Accessed 2 July, 2024. https://www.formycon.com/en/blog/press-release/formycon-receives-fda-approval-for-fyb203-ahzantive/