US FDA approves new biosimilars for blockbuster eye drug Eylea
Key Takeaways
- The FDA approved Yesafili and Opuviz as the first interchangeable biosimilars to Eylea.
- Yesafili and Opuviz showed no clinically meaningful differences in efficacy, safety or immunogenicity from Eylea.
The FDA approved Yesafili and Opuviz as the first interchangeable biosimilars to the anti-VEGF drug Eylea (aflibercept, Regeneron), according to a press release from the FDA. Yesafili (aflibercept-jbvf, Biocon Biologics) and Opuviz (aflibercept-yszy, Samsung Bioepis) are intended to treat wet age-related macular degeneration (AMD), macular edema secondary to retinal vein occlusion, diabetic macular edema and diabetic retinopathy as a 2 mg injection into the eye. The approvals were supported by a review of scientific evidence that found Yesafili and Opuviz are highly similar to the reference product Eylea with no clinically meaningful differences in efficacy, safety or immunogenicity from Eylea, the release said.
The approval of Yesafili and Opuviz would allow interchangeability, i.e., Eylea’s substitution with biosimilars without the need for a doctor’s advice. “Substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state … similar to how generic drugs are substituted for brand-name drugs,” the release said.
It is not immediately clear when the therapies would be launched. Regeneron has filed lawsuits against companies such as Amgen and Biocon, which are seeking to bring Eylea biosimilars to the U.S. market.
The FDA previously approved ranibizumab-nuna (Byooviz), a Biogen/Samsung Bioepis biosimilar to the anti-VEGF reference ranibizumab (Lucentis) for wet AMD, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.
Edited by Miriam Kaplan, PhD
Sources:
Anthony DeFino, “FDA approves aflibercept biosimilars Yesafili, Opuviz,” Healio Ocular Surgery News, May 21, 2024; see source article
Leroy Leo and Sriparna Roy, “US FDA approves new biosimilars for blockbuster eye drug Eylea,” Medscape Medical News, May 20, 2024, see source article
Charles Bankhead, “FDA approves first interchangeable biosimilars to aflibercept for AMD,” MedPage Today, May 20, 2024; see source article