Biocon Bags US FDA Approval for Yesintek® Single-Dose Prefilled Autoinjector

Biocon Bags US FDA Approval for Yesintek® Single-Dose Prefilled Autoinjector​

Biocon Limited's U.S. subsidiary has secured supplemental approval from the U.S. Food and Drug Administration (FDA) for enhanced forms of its immunotherapy product, Yesintek®. The approval expands access to critical treatment options for patients suffering from various autoimmune conditions in the United States.

The FDA granted the supplemental approval for two specific formulations: the Yesintek® 45 mg/0.5 ml single-dose prefilled autoinjector and the Yesintek® 90 mg/ml single-dose prefilled autoinjector. This development follows the original U.S. FDA approval of Yesintek®, which was granted on November 29, 2024.

The introduction of these specialized delivery formats provides patients with an important new treatment option, supporting more tailored therapeutic approaches across different patient needs and care settings.

Yesintek® is indicated for the management of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients aged six years and older. Furthermore, it is approved for treating moderate to severely active Crohn's disease and ulcerative colitis in adults. These autoimmune conditions affect thousands of Americans.

This supplemental FDA approval strengthens Biocon's presence in the immunology product portfolio within the United States and underscores the company’s commitment to increasing access to affordable medications globally.

BIOCON Stock Price Movement​

As of 2:10 PM, shares of Biocon Limited are edging higher to ₹416.95, gaining 1.20% in the market trade as they climbed by ₹4.95. The stock demonstrates healthy volume, with 1.32 million shares trading during the live session.