Yesafili

BLA 761274, held by Biocon Biologics Inc. Aflibercept-Jbvf.

As of Nov 13, 2026, BLA 761274 (Yesafili), held by Biocon Biologics Inc, was first approved by FDA on May 20, 2024, with 3 approved supplements and 0 published complete response letters.

First approved: May 20, 2024
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

YESAFILI is indicated for the treatment of: YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:

Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)
Diabetic Macular Edema (DME)
Diabetic Retinopathy (DR) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Diabetic Macular Edema (DME) 1.4 Diabetic Retinopathy (DR)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 20, 2024	Original application	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Yesafili2MG(0.05ML,40MG/ML) · injectable;injection	Aflibercept-Jbvf	Rx

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 22, 2026	Supplement 6Manufacturing	Approved	Label
Aug 20, 2026	Supplement 8Labeling · Standard review	Approved	Label Letter
Jan 13, 2026	Supplement 1Manufacturing	Approved	Label Letter
May 20, 2024	Original application	Approved	Review Label Letter

Identifiers

Application: BLA 761274
Drugs@FDA: Overview at FDA
Company: Biocon Biologics

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters