Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals

Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. 

In its first-to-file application for Yesafili, Biocon Biologics announced their US FDA approval for the vascular endothelial growth factor inhibitor, with indications for several different ophthalmology conditions. The product is intended to treat neovascular age-related macular degeneration, visual impairment from macular oedema secondary to retinal vein occlusion, visual impairment from diabetic macular oedema, and visual impairment from myopic choroidal neovascularisation.  

The US FDA’s approval of Yesafili marks an opportunity for expansion for Bion Biologics into the US ophthalmology market after approvals in Europe and the UK. Yesafili was the first biosimilar for Eylea to be accepted in the UK. A launch date in Canada is expected to be no later than July 2025. “The FDA approval of Yesafili as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics, marking our entry into ophthalmology, a new therapeutic are in the United States,” commented Shreehas Tambe, CEO & Managing Director of Biocon Biologics. 

Regeneron has previously taken companies to court over Eylea biosimilars, with lawsuits filed against companies like Amgen and Biocon. In the US market, Regeneron brought in US$5.72 billion in Eylea sales in 2023. The pressure is mounting for the pharmaceutical company as more biosimilar threats loom. 

Matt Erick, Chief Commercial Officer of Advanced Markets at Biocon Biologics, stated “Biosimilars are crucial for making healthcare more affordable and accessible. 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 commercialisation of biosimilars.” 

Sources: 

1. Biocon Biologics secures USFDA approval for biosimilar product to treat ophthalmology conditions [Accessed May 22, 2024] https://www.deccanherald.com/business/biocon-biologics-secures-usfda-approval-for-biosimilar-product-to-treat-ophthalmology-conditions-3031832 

2. Biocon Biologics obtains US FDA approval for biosimilar afilbercept for Yesafili. Enters US ophthalmology market [Accessed May 22, 2024] https://www.biocon.com/biocon-biologics-obtains-u-s-fda-approval-for-biosimilar-aflibercept-for-yesafili-enters-u-s-ophthalmology-market/  

3. US FDA approves two biosimilars for blockbuster eye drug Eylea [Accessed May 22, 2024] https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-biocon-units-biosimilar-blockbuster-eye-drug-eylea-2024-05-20/