Eylea will eventually have competition in the US, as the FDA approved two interchangeable biosimilars.
Monday’s approvals for Biocon Biologics’ Yesafili and Samsung Bioepis and Biogen’s Opuviz are based on the companies’ ability to show that their aflibercept competitors have no clinically meaningful differences from brand-name Eylea. Yesafili won approval in the UK last November and in Europe last September.
“This evidence included comparisons of each product to Eylea on an analytical level using an extensive and robust battery of physicochemical tests and biological assays, and in a comparative clinical study in patients,” FDA said in announcing the approvals. Sandoz also has another Eylea biosimilar in the works.
While most interchangeable biosimilars have to run switching studies to win approval, FDA confirmed to Endpoints that neither interchangeable for Eylea had to run such studies. The agency said “the risk of a clinically impactful immunogenic response when alternating or switching between Yesafili and Eylea or Opuviz and Eylea is low. Thus, a switching study that compares immunogenic responses to assess whether the risk of alternating or switching between Yesafili and Eylea or Opuviz and Eylea were unnecessary for either product.”
But because of remaining patents on Eylea, analysts don’t expect either of the two new biosimilars to launch until 2027.
In August, Regeneron also launched a high-dose version of Eylea that it hopes will become the standard of care in several retinal diseases. In its first-quarter filing, Regeneron recorded $200 million in US sales of the high-dose version, and about $2.3 billion in worldwide sales of Eylea and Eylea HD.
Competition from interchangeable biosimilars is increasing for some of the biggest drugs in the world, including AbbVie’s Humira. Regeneron reported more than $12 billion in Eylea sales in 2022 and 2023. Eylea may also be up for Medicare negotiations in the next few years — in 2022, Medicare Part B spent more money on Eylea than any other drug except Merck’s Keytruda.
While not mentioning the US launch date, Biocon said in a statement that it will launch in Canada no later than July 1, 2025.
“With this approval, we now have two ophthalmology biosimilars approved by the FDA, marking an important step towards expanding treatment options for patients suffering from retinal disorders,” Byoungin Jung, VP and regulatory affairs team leader at Samsung Bioepis, said in a statement.
Editor’s note: Updated with more on the switching studies from the FDA and comments from Biocon and Samsung Bioepis.