Biocon Limited announced the U.S. launch of YESAFILI (aflibercept-jbvf), its interchangeable biosimilar to EYLEA (aflibercept) 2mg, in the commercial market.
This news follows 2 years after the company was granted FDA approval—and just over a year since a U.S. court cleared Biocon to launch.
First, a refresher on YESAFILI.
If you recall: The FDA approved YESAFILI in May 2024 as a “first-to-file” generic equivalent of EYLEA with four 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)
Take note: The vascular endothelial growth factor (VEGF) inhibitor was not approved for retinopathy of prematurity (ROP), EYLEA’s third indication.
And its prescribing information?
That can be found here. Included in the PI:
- Recommended dosing for each indication
- Warnings and precautions
- Contraindications
Now, remind me what interchangeable designation signifies.
The basics: An FDA-approved biosimilar meeting additional requirements that prove alternating (or switching) between it and its original reference product carries no greater risk of adverse effects than sticking with the original.
A major difference from standard biosimilars: An interchangeable biosimilar does not require a new prescription and can be automatically substituted for the reference product by a pharmacist—without consulting the prescribing physician.
- Think: how generic drugs can be swapped for name-brand drugs, with an emphasis on representing a potentially lower-cost alternative for patients
Gotcha. And, could we circle back to that settlement you mentioned?
That’s (obviously) in the past, but if you’re interested, click here for our coverage.
So where can YESAFILI be purchased?
Good question. While aflibercept appears on Biocon’s biosimilar page, it’s unclear when or how eyecare providers can begin to prescribe it for their patients.
We’d recommend reaching out to the company directly for more information on availability.