Biocon arm gets supplemental USFDA approval for autoimmune disease drug

Biocon Ltd on Tuesday said its subsidiary has received supplemental approval from the US health regulator for Yesintek prefilled autoinjector.

Yesintek is indicated for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.

The company's subsidiary in the United States has received supplemental US Food and Drug Administration (USFDA) approval for Yesintek of strengths 45 mg/0.5 ml single-dose prefilled autoinjector and 90 mg/ml single-dose prefilled autoinjector, Biocon said in a regulatory filing.

Yesintek was originally approved by the USFDA on November 29, 2024, it added.

The Yesintek single-dose prefilled autoinjector offers patients with another important treatment option.

This new delivery format supports more tailored treatment approaches across different care settings and patient needs, the company said.

Yesintek is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult and pediatric patients