BIOCONNSEBIOCON LIMITED.· PharmaceuticalsHighPositive
Announced Tue, 18 Aug · 08:40 IST

Biocon gets U.S. FDA nod for Yesintek autoinjector format

Regulatory Product ApprovalBusiness Updates View source PDFExplain this filing

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AI summary

Biocon's U.S. subsidiary received supplemental U.S. FDA approval for Yesintek (ustekinumab-kfce) single-dose prefilled autoinjector in 45 mg/0.5 ml and 90 mg/ml strengths. The drug treats moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. Yesintek was originally approved in November 2024. This new delivery format strengthens Biocon's U.S. immunology portfolio.

Likely market impact

New patient-friendly delivery format expands Biocon's U.S. immunology portfolio, which could support revenue growth.