FDA approves aflibercept-mrbb (Ahzantive), Formycon’s biosimilar to Eylea

News
Article

The company also submitted a marketing authorization application with the European Medicines Agency.

FDA graphic with physician in background Image Credit: AdobeStock/wladimir1804

Image Credit: AdobeStock/wladimir1804

The US Food and Drug Administration (FDA) has approved biosimilar to Eylea, aflibercept-mrbb (Ahzantive), for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD).

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

In addition to Ahzantive, 2 other aflibercept biosimilars were recently approved by the FDA, Biocon Biologics's Yesafili (aflibercept-jbvf) and Samsung Bioepis Opuviz (aflibercept-yszy).

The news was announced in a press release from biosimilar developer Formycon AG and its licensing partner Klinge Biopharma.1

In the press release,1 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 the approved Lucentisbiosimilar FYB201, he believes the company has an “outstanding position in ophthalmic biosimilar therapies.”

According to the company, 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.

Furthermore, the company stated that 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 Eyleain patients with nAMD.

In addition to the FDA approval, the company also submitted a marketing authorization 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; July 1, 2024. Accessed July 2, 2024. https://www.formycon.com/en/blog/press-release/formycon-receives-fda-approval-for-fyb203-ahzantive/

Newsletter

Want more insights like this? Subscribe to Optometry Times and get clinical pearls and practice tips delivered straight to your inbox.

Recent Videos
Dana Shannon, OD, FAAO, shares pearls on spotting red flags in need of referral and enhancing patient care with follow-up compliance.
Dana Shannon, OD, FAAO, detailed a lecture she gave at the NOA Midwestern Symposium earlier this month.
CRU 2025 provided the latest insights regarding glaucoma, dry eye disease, retina, myopia, neurotrophic keratitis, and keratoconus.
Rachelle Lin, OD, MS, FAAO
Melissa Barnett, OD, FAAO, FSLS, FBCLA, gave 2 presentations alongside other ODs and MDs at CRU 2025.
Rachelle Lin, OD, MS, FAAO, at CRU Eye Symposium 2025
Melissa Tawa, OD, FAAO, provides insights to take glaucoma management from reactive to proactive in presentations given at CRU 2025 in Napa, California.
Rachelle Lin, OD, MS, FAAO, details her presentation on inherited retinal diseases at CRU 2025.
Setting the stage in LA: Neda Shamie, MD, on the 19th annual Controversies in Modern Eye Care meeting
Jennifer Li, MD, details a talk she gave alongside Melissa Barnett, OD, FAAO, FSLS, FBCLA, at CRU 2025 in Napa, California.
© 2025 MJH Life Sciences

All rights reserved.