Biocon Limited’s U.S. subsidiary has received supplemental U.S. FDA approval for its Yesintek® (ustekinumab-kfce) single-dose prefilled autoinjector. This approval covers both 45 mg/0.5 ml and 90 mg/ml strengths, offering patients an important new treatment option for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. This development strengthens Biocon’s immunology portfolio in the United States.
Biocon Secures Key U.S. FDA Approval for Yesintek® Autoinjector
Biocon Limited announced today that its U.S.-based subsidiary has successfully obtained supplemental approval from the U.S. Food and Drug Administration (FDA) for its Yesintek® (ustekinumab-kfce) single-dose prefilled autoinjector. The approval encompasses both the 45 mg/0.5 ml and 90 mg/ml dosage strengths, providing an enhanced delivery system for patients.
Expanded Treatment Options and Market Reach
This new delivery format is designed to offer patients greater convenience and support more tailored treatment approaches across various care settings and individual patient needs. Yesintek® is a critical treatment for a range of debilitating autoimmune conditions, including moderate to severe plaque psoriasis and active psoriatic arthritis in adult and pediatric patients aged 6 years and older, as well as moderate to severely active Crohn’s disease and ulcerative colitis in adults. These conditions affect tens of thousands of individuals in the United States.
Strengthening Immunology Portfolio
The supplemental approval by the U.S. FDA is a significant step for Biocon, bolstering its comprehensive portfolio of immunology products available in the United States. This reaffirms the company’s ongoing commitment to improving patient access to affordable and effective medicines globally. Yesintek® was initially approved by the U.S. FDA on November 29, 2024.
Source: BSE
