Date: August 18, 2026
Product Approval Disclosure
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
- Yesintek® 90 mg/ml single-dose prefilled autoinjector
Product Background
Yesintek® was originally approved by the U.S. FDA on November 29, 2024.
The new autoinjector format offers patients an additional treatment option and supports more tailored treatment approaches across different care settings and patient needs.
Therapeutic Indications
Yesintek® is indicated for the treatment of:
- Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older
- Active psoriatic arthritis in adult and pediatric patients 6 years of age and older
- Moderate to severely active Crohn's disease in adults
- Ulcerative colitis in adults
The product addresses a range of debilitating autoimmune conditions that affects tens of thousands of Americans.
Strategic Impact
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.
Sections Not Specified
- KMP / Board / Auditor Changes: Not specified
- Dividend Declaration: Not specified
- Board Meeting Outcomes: Not specified
- Financial Results: Not specified
- Auditor's Report: Not specified
- Disinvestment / Strategic Actions: Not specified
- Media Release / Investor Communication: Limited to company spokesperson statement