Regeneron has had its hands full this year contending with regulatory setbacks, Amgen's marketed Eylea biosimilar and Roche's hard-charging ophthalmology rival Vabysmo. Next year, the biosimilar competition to the New York drugmaker's blockbuster eye drug Eylea is only likely to ratchet up.
Regeneron has inked another settlement related to Eylea biosimilars, this one with Alvotech and Teva, enabling the partners to launch their product "in the fourth quarter of 2026, or earlier under certain circumstances," according to a Dec. 19 press release from Alvotech.
Alvotech and Teva's Eylea biosim, AVT06, has been under review at the FDA since February. In a Feb. 18 press release, the partners said the review was expected to be complete by the end of this year. Teva's online pipeline lists the program as "under regulatory review."
The partners didn't disclose the "certain circumstances" that could enable a launch earlier in 2026.
For Regeneron, the agreement follows several other settlements related to Eylea biosimilars. The company's deal with Sandoz appears to be structured similarly to Alvotech and Teva's, featuring a launch date "in the fourth quarter of 2026, or earlier in certain circumstances," according to a Sept. 9 press release from the Swiss drugmaker.
Formycon, too, touted the same timeline in its own Oct. 2 press release.
Under Celltrion's deal, meanwhile, the South Korean drugmaker is allowed to launch its biosimilar version of Eylea on Dec. 31, 2026, Regeneron said in an Oct. 20 press release.
All of this comes as Amgen builds up its head start in the Eylea biosimilar market. After a legal win more than a year ago, Amgen launched (PDF) its Eylea biosim Pavblu in October 2024. The drug generated $442 million in the first nine months of 2025.
As for Regeneron, the company has been shifting its focus to the high-dose version of Eylea, which crossed the regulatory finish line back in 2023.
Last month, Eylea HD picked up new approvals for monthly dosing and to treat macular edema following retinal vein occlusion, adding to its three other approved ophthalmology uses. At the time, an analyst with Evercore ISI wrote that the new approvals put the long-acting Eylea HD on more even footing with Roche's formidable Vabysmo.
Through the first nine months of 2025, Regeneron's combined Eylea and Eylea HD sales were down 16% versus the same period in 2024 to just under $6 billion.