Just shy of 1 year since the FDA approved Biocon Biologics Limited’s YESAFILI (aflibercept-jbvf) as an interchangeable biosimilar for Regeneron Pharmaceutical Inc’s EYLEA, the two companies have agreed to a settlement and license agreement.
What this means: Biocon is now cleared to launch its generic drug in the United States.
First, a rundown on Biocon.
Biocon Biologics is a subsidiary of Bangalore, India-based Biocon Ltd.—the country’s largest biopharmaceutical company.
Its purpose: To develop, manufacture, and commercialize cost-effective biosimilars and generic formulations across the globe.
Its current portfolio: Extends to 20+ biosimilars in varying stages of clinical development and regulatory approval, with nine commercialized across 120+ countries in North America and Europe, as well as Japan, Australia, and New Zealand (JANZ)
- See here for a look at the company’s target therapeutic areas.
How did it get into the U.S. biosimilar business?
We’ll take it back to 2009, when Biocon partnered with then-Milan N.V.—which merged with Upjohn in 2019 and formed Viatris, Inc. in 2020—to develop a portfolio of biosimilar antibodies for the global markets.
More recently: In 2022, Biocon acquired Viatris’s international biosimilars division to operate as a “fully integrated global biosimilars company.”
Got it. Now for a rundown on this biosimilar.
As a vascular endothelial growth factor (VEGF) inhibitor, the FDA approved YESAFILI in May 2024 as a “first-to-file” generic equivalent of EYLEA with the following ophthalmic indications:
- Diabetic macular edema (DME)
- Diabetic retinopathy (DR
- Macular edema following retinal vein occlusion (RVO; branch or central)
- Neovascular (wet) age-related macular degeneration (AMD)
The only difference: While EYLEA was granted FDA approval for retinopathy of prematurity (ROP) in 2023, that indication does not extend to YESAFILI.
How does the prescribing information compare between the two?
They’re virtually identical—see here for YESAFILI and click here for EYLEA.
- Plus: Check out potential warnings and ocular adverse reactions associated with their use.
This equivalency also extends to the recommended dosages for each indication.
- DME and DR
- 2 mg (0.05 mL of 40 mg/mL solution) intravitreally (IVT) administered every 4 weeks for the first five injections, then 2 mg once every 8 weeks
- Macular edema following RVO
- 2 mg injected IVT once every 4 weeks
- Wet AMD
- 2 mg injected IVT every 8 weeks following an initial monthly dose for 3 months
Got it. Now explain this settlement situation.
Biocon and Regeneron reached a settlement agreement to dismiss:
- A pending appeal filed at the United States Court of Appeals for the Federal Circuit of a patent (US11084865 [‘865 patent])
- Pending litigation at the U.S. District Court for the Northern District of West Virginia, Clarksburg Division
To note: This appeal was in regards to Regeneron suing Mylan (which Biocon is a distributor of) for infringement of a number of patents (including the ‘865 patent) that relates to EYLEA.
- Also keep in mind: Regeneron is no stranger to filing lawsuits against other potential EYLEA biosimilars (and winning).
So … has a YESAFILI launch date been set yet?
Sort of! Biocon reported plans to launch the biosimilar in the United States within the second half (H2) of 2026—or potentially even earlier (pending certain undisclosed circumstances).
Nice! Also, sort of related: Wasn’t a similar settlement reached in Canada?
Good memory! And yes, there was.
In March 2024, Biocon signed a settlement agreement with Regeneron and Bayer Inc. following six parallel patient infringement proceedings relating to YESAFILI and EYLEA in Canada’s federal court.
- To note: YESAFILI was granted tentative Canadian regulatory approval in March 2023 as a biosimilar to EYLEA (subject to resolving any patent issues).
And the result of that settlement: Biocon secured a launch date for the biosimilar of no later than July 1, 2025.