BSECompany Update2d ago · 18 Aug 2026, 08:42 am
Company Statement
Biocon Ltd · 532523
✦ AI Summary▲ PositiveProduct Launch
Biocon Ltd has received supplemental U.S. FDA approval for Yesintek® (ustekinumab-kfce) single-dose prefilled autoinjector, expanding its immunology portfolio in the United States.
Analysis Scores
Earnings Impact8/10
Growth Catalyst9/10
Governance Concern1/10
Regulatory Risk2/10
Balance Sheet Risk1/10
Liquidity Impact9/10
Market Sentiment9/10
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Biocon Ltd - 532523 - Company Statement
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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/2026-27/60
August 18, 2026
To To
The Manager, The Manager,
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: Company Statement
Dear Sir/Madam,
Please find enclosed Company Statement w.r.t. “Biocon Announces U.S. FDA Approval for
Yesintek® (ustekinumab-kfce) Single-dose Prefilled Autoinjector”.
The above information will also be available on the website of the Company at www.biocon.com.
Kindly take the same on record and acknowledge.
Thanking You,
Yours faithfully,
For Biocon Limited
Rajesh U. Shanoy
Company Secretary and Compliance Officer
M. No.: ACS 16328
Encl: Company Statement
NOTIFICATION TO STOCK EXCHANGE
COMPANY STATEMENT
Biocon Announces U.S. FDA Approval for Yesintek®
(ustekinumab-kfce) Single-dose Prefilled Autoinjector
Bengaluru, Karnataka, India, August 18, 2026
Biocon Limited’s subsidiary in the United States has received supplemental U.S. Food and
Drug Administration (FDA) approval for Yesintek® 45 mg/0.5 ml single-dose prefilled
autoinjector and Yesintek® 90 mg/ml single-dose prefilled autoinjector. Yesintek® was
originally approved by the U.S. FDA on November 29, 2024.
The Yesintek® single-dose prefilled autoinjector offers patients with another important
treatment option. This new delivery format supports more tailored treatment approaches
across different care settings and patient needs.
Yesintek® is indicated for the treatment of moderate to severe plaque psoriasis and active
psoriatic arthritis in adult and pediatric patients 6 years of age and older, and moderate to
severely active Crohn’s disease and ulcerative colitis in adults—a range of debilitating
autoimmune conditions that affects tens of thousands of Americans.
This supplemental approval enhances Biocon’s comprehensive portfolio of immunology
products in the United States and reaffirms the company’s commitment to improving access
to affordable medicines for patients around the world.
– Company Spokesperson