BSECompany Update5d ago · 3 Aug 2026, 08:21 am
Commercial Launch of Product
Biocon Ltd · 532523
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Biocon Ltd has commercially launched Yesafili, a biosimilar Aflibercept, in the United States, expanding its global presence in ophthalmology and increasing access to life-changing medicines for patients with eye conditions.
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Biocon Ltd - 532523 - Commercial Launch Of Product
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Biocon Limited
20th KM, Hosur Road
Electronic City
Bangalore 560 100, India
T 91 80 2808 2808
F 91 80 2852 3423
CIN : L24234KA1978PLC003417
www.biocon.com
BIO/SECL/TG/2026-27/47
August 03, 2026
To To
The Secretary The Secretary
BSE Limited National Stock Exchange of India Limited
Department of Corporate Services Corporate Communication Department
Phiroze Jeejeebhoy Towers, Exchange Plaza, Bandra Kurla Complex
Dalal Street, Mumbai – 400 001 Mumbai – 400 051
Scrip Code - 532523 Scrip Symbol – BIOCON
Subject: Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations,
2015
Dear Sir/Madam,
Pursuant to Regulation 30 read with Part A of Schedule III of the Securities and Exchange Board of India (Listing
Obligations and Disclosure Requirements) Regulations, 2015 (‘SEBI Listing Regulations’), we hereby inform you
regarding the Commercial Launch of Yesafili™, a Biosimilar Aflibercept in the United States.
The details required under Regulation 30 of the SEBI Listing Regulations read with SEBI Circular No.
HO/49/14/14(7)2025-CFD-POD2/I/3762/2026 dated January 30, 2026, are enclosed herewith as ‘Annexure A’.
Further, Press Release titled “Biocon Announces U.S. Commercial Launch of Yesafili™, a Biosimilar to Regeneron’s
Eylea® 2 mg” is also enclosed herewith as ‘Annexure B’.
This intimation will also be available on website of the Company at www.biocon.com.
Request you to kindly take this intimation on record and acknowledge.
Thanking You,
Yours faithfully
For Biocon Limited
Rajesh U. Shanoy
Company Secretary and Compliance officer
ICSI Membership Number: A16328
Enclosed: As above
ANNEXURE A
Details as required under the Regulation 30 of the SEBI Listing Regulations read with SEBI Circular No.
HO/49/14/14(7)2025-CFD-POD2/I/3762/2026 dated January 30, 2026:
S. Particulars Details
1. Name of the Product Yesafili™ (aflibercept)
2. Date of Launch August 03, 2026
3. Category of the Product Biosimilar
4. Whether caters to domestic/ international market International market
5. Name of the countries in which the product is United States
launched (in case of international)
Annexure B
PRESS RELEASE
Biocon Announces U.S. Commercial Launch of Yesafili™, a
Biosimilar to Regeneron’s Eylea® 2 mg
• Yesafili™ (aflibercept-jbvf) now available in the United States as an U.S. FDA-approved
interchangeable biosimilar to EYLEA 2 mg
• Potential benefit to the ~20 million adults in the U.S. with age-related macular degeneration
and other serious eye conditions
BENGALURU, India and BRIDGEWATER, N.J., United States: August 3, 2026
Biocon Limited (BSE: 532523; NSE: BIOCON), an innovation-led global biopharmaceutical company,
today announced the commercial launch of Yesafili™ (aflibercept-jbvf) in the United States. YESAFILI,
a vascular endothelial growth factor (VEGF) inhibitor used to treat various types of ophthalmology
conditions, is a biosimilar of its reference product EYLEA® (aflibercept) 2 mg. The product was
approved previously and granted interchangeable designation* by the U.S. Food and Drug
Administration in May 2024, allowing substitution at the pharmacy level in accordance with state laws.
Shreehas Tambe, CEO & Managing Director, Biocon Ltd., said, “The launch of Yesafili™️ in the U.S.
marks an important step in expanding the global availability of biosimilar Aflibercept 2 mg for patients
with eye conditions. This milestone further strengthens our presence in ophthalmology and builds on
our FDA approval as one of the first interchangeable biosimilars to Eylea®️ 2 mg, advancing access to
life-changing medicines for patients around the world.”
An estimated 19.8 million Americans are living with age-related macular degeneration (AMD) while
U.S.1 sales of aflibercept reached approximately $5.89 billion in 2023,2 underscoring the growing need
for effective treatment options.
Epidemiology:
Macular degeneration, specifically age-related macular degeneration (AMD), is a significant health
concern, especially as the population ages. It is a leading cause of irreversible vision loss in adults over
603.In 2019, an estimated 19.8 million (12.6%) Americans aged 40 and older were living with AMD, with
1.49 million (0.94%) living with vision threatening.4
About YESAFILI (aflibercept-jbvf)
The approval for YESAFILI (aflibercept-jbvf) was based on a comprehensive package of analytical,
nonclinical and clinical data, which confirmed that YESAFILI is highly similar to Eylea® 2 mg. In a Phase
3 INSIGHT Study, YESAFILI was compared with Eylea® 2 mg in patients with Diabetic Macular Edema.
*Vial is interchangeable. Pre-filled syringe has provisional interchangeability status.
1 Prevalence of Age-Related Macular Degeneration in the US in 2019 | Geriatrics | JAMA Ophthalmology | JAMA
Network
2 Regeneron Fourth Quarter and Full Year 2023 Financial and Operating Results. February 2, 2024.
3 Macular Degeneration: Symptoms, Diagnosis & Treatment
4 VEHSS Modeled Estimates: Age-Related Macular Degeneration (AMD) | Vision and Eye Health Surveillance
System (VEHSS) | CDC
Study demonstrated that there were no clinically meaningful differences between YESAFILI and Eylea 2
mg in terms of pharmacokinetics, safety, efficacy, and immunogenicity.
INDICATIONS AND USAGE:
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)
WARNINGS AND PRECAUTIONS:
• YESAFILI is contraindicated in patients with Ocular or periocular infection, Active intraocular
inflammation and Hypersensitivity to aflibercept.
• Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may
occur following intravitreal injections. Patients and/or caregivers should be instructed to report
any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal
vasculitis without delay and should be managed appropriately.
• Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
• There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF
inhibitors.
Please refer to the full Patient Information for detailed safety information. To report SUSPECTED
ADVERSE REACTIONS, contact Biocon at 1-833-986-1468.
About Biocon Limited
Biocon Limited (BSE: 532523, NSE: BIOCON) is a global biopharmaceutical company driven by its purpose to
provide affordable, life-changing medicines to patients worldwide. Headquartered in Bengaluru, India, Biocon
addresses some of the world’s most pressing healthcare challenges across chronic and non-communicable
diseases by offering both biosimilars and generics at scale across geographies. Through this diversified portfolio,
Biocon focuses on areas of high unmet need, spanning key therapy areas including diabetes, oncology, obesity,
cardiovascular diseases, immunology, ophthalmology, and bone health. The Company has pioneered several
industry firsts that have helped shape the global biosimilars landscape. To date, the company has commercialized
12 biosimilar products and 30+ generic formulations globally. It has robust research and development pipeline of
20+ biosimilar assets, as well as GLP-1 peptides and other complex generics. With an integrated lab-to-patient
model, Biocon brings together research and development, manufacturing, and commercial capabilities to ensure
reliable and scalable supply of medicines. The company operates in more than 120 countries, supported by seven
manufacturing sites, three R&D sites, 18 offices worldwide, and a workforce of over 9,500 employees. Biocon has
been included in the S&P Global Sustainability Yearbook 2026 for the fourth consecutive year, underscoring its
commitment to sustainable and responsible growth. Website: www.biocon.com Follow us on X: @bioconlimited
LinkedIn: Biocon
Forward-Looking Statements
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