
USFDA18 Aug 2026, 08:43 am
Biocon Subsidiary Gets US FDA Approval for Yesintek Autoinjector
AI Summary
Biocon Limited's US subsidiary has received supplemental U.S. Food and Drug Administration (FDA) approval for Yesintek® (ustekinumab-kfce) in both 45 mg/0.5 ml and 90 mg/ml single-dose prefilled autoinjector formats. This approval, building on the original approval from November 29, 2024, offers patients an additional treatment option for moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis. The new delivery format aims to provide more tailored treatment approaches and enhances Biocon's immunology product portfolio in the US, reinforcing its commitment to affordable medicine access.
Key Highlights
- US FDA grants supplemental approval for Yesintek autoinjector.
- New delivery format enhances treatment options for autoimmune conditions.
- Strengthens Biocon's immunology product portfolio in the US.
- Focus on improving access to affordable medicines globally.
Price Impact
More from BIOCON