It's heating up in the kitchen... The FDA has now approved two...

It's heating up in the kitchen...

The FDA has now approved two biosimilars of Eylea, the first marketing approvals it has given for Eylea copy drugs.

Biocon Biologics' Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen's Opuviz (aflibercept-yszy) carry interchangeable designations which allows them to be substituted with biosimilars without the need for a doctor's advice.

Both Yesafili and Opuviz are administered intravitreally as a 2 mg dose. Like Eylea, the biosimilars will be used to treat wet AMD, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.

In anticipation of the challenge from biosimilars, Regeneron has been focusing on its potentially longer duration 8 mg dose Eylea but this drug also faces pressure from rival drugs including Roche's less frequently administered 6mg dose Vabysmo.

US sales last year from the regular 2mg dose of Eylea were US$5.72 bn.


FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions | FDA

Regulatory tracker: FDA approves Eylea biosimilars from Biocon Biologics, Biogen | Fierce Pharma

US FDA approves two biosimilars for blockbuster eye drug Eylea | Reuters