BSECompany Update5d ago · 3 Aug 2026, 08:24 am

Press Release

Biocon Ltd · 532523

✦ AI Summary▲ PositiveProduct Launch

Biocon Ltd has announced the commercial launch of Yesafili, a biosimilar to Eylea 2 mg, in the United States. The product is a vascular endothelial growth factor (VEGF) inhibitor used to treat various types of ophthalmology conditions.

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Growth Catalyst8/10
Governance Concern1/10
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Liquidity Impact8/10
Market Sentiment9/10

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Biocon Ltd - 532523 - Announcement under Regulation 30 (LODR)-Press Release / Media Release

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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 [Showing first 8,000 characters — download PDF for full document]