Biocon subsidiary wins US approval for psoriasis autoinjector

Biocon Ltd announced Tuesday that its United States subsidiary has obtained supplemental approval from the US Food and Drug Administration for Yesintek prefilled autoinjectors, marking an expansion of the company's immunology portfolio in the American market.

The regulatory clearance covers two formulations: Yesintek 45 mg/0.5 ml and 90 mg/ml, both in single-dose prefilled autoinjector format. The drug is indicated for treating moderate-to-severe plaque psoriasis and active psoriatic arthritis in adult and pediatric patients. Biocon's original FDA approval for Yesintek was granted on November 29, 2024.

The prefilled autoinjector delivery system offers healthcare providers and patients greater flexibility in managing autoimmune conditions across diverse clinical settings. The company said the new format enables more personalized treatment approaches, allowing clinicians to tailor therapy based on individual patient requirements and care environments.

The supplemental approval underscores Biocon's commitment to expanding its presence in the lucrative US biologics market, where demand for convenient, self-administered treatments continues to grow. The autoinjector format addresses patient preferences for ease of use while maintaining therapeutic efficacy in managing chronic inflammatory conditions.