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/
Recent Videos
Dr. Analisa Arosemena discusses glaucoma at EyeCon 2024
Dr. Mark Dunbar chats about his EyeCon 2024 presentation about diabetic eye care
EyeCon 2024: Insights on transforming ocular surface disease management
EyeCon 2024: Kelly Nichols, OD, and A. Paul Chous, OD, discuss multidisciplinary care and AI in diabetes management
Dr. Ferrucci summarizes his Vision Expo West presentations and shares clinical pearls for managing retinal cases.
Laura Periman, MD, discusses a case study in Demodez blepharitis
Jessilin Quint, OD, MBA, FAAO, overviews her presentations at Vision Expo West.
Jeffry Gerson, OD, FAAO, chats with Optometry Times about his talks about retina conditions at Vision Expo West
Marc Bloomenstein, OD, FAAO, gives overview of education available at Vision Expo West
Mile Brujic, OD, FAAO, gives overview of how to start a speciality contact lens practice
© 2024 MJH Life Sciences

All rights reserved.