FDA approves aflibercept biosimilars Yesafili, Opuviz
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Key takeaways:
- Yesafili and Opuviz showed no clinically meaningful differences in efficacy, safety or immunogenicity from Eylea.
- Yesafili was previously approved in Europe and the United Kingdom.
The FDA approved Yesafili and Opuviz as the first interchangeable biosimilars to Eylea, according to a press release from the FDA.
Yesafili (aflibercept-jbvf, Biocon Biologics) and Opuviz (aflibercept-yszy, Samsung Bioepis) are intended to treat neovascular age-related macular degeneration, macular edema secondary to retinal vein occlusion, diabetic macular edema and diabetic retinopathy as a 2 mg intravitreal injection.
“Yesafili will offer ophthalmologists an important new option for patients impacted by macular degeneration and diabetic retinopathy, from a company with a long history of delivering high-quality, science-driven medicines, solely focused on the development and commercialization of biosimilars,” Matt Erick, chief commercial officer of advanced markets at Biocon Biologics, told Healio.
The approvals are supported by a review of scientific evidence that found Yesafili and Opuviz are highly similar to the reference product Eylea (aflibercept, Regeneron) with no clinically meaningful differences in efficacy, safety or immunogenicity from Eylea, the release said.
According to a press release from Biocon, Yesafili was approved in Europe and the United Kingdom in 2023. Biocon intends to launch Yesafili in Canada by July 1, 2025.
Reference:
- Biocon Biologics obtains U.S. FDA approval for biosimilar aflibercept for Yesafili. Enters U.S. ophthalmology market. https://www.bioconbiologics.com/biocon-biologics-obtains-u-s-fda-approval-for-biosimilar-aflibercept-for-yesafili-enters-u-s-ophthalmology-market/. Published May 21, 2024. Accessed May 21, 2024.
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