Biocon Limited has announced that its US subsidiary has received supplemental approval from the US Food and Drug Administration (FDA) for the single-dose prefilled autoinjector versions of Yesintek® (ustekinumab-kfce). The approval covers Yesintek® 45 mg/0.5 ml and 90 mg/ml single-dose prefilled autoinjectors. The product was first approved by the US FDA on November 29, 2024. The newly approved delivery format gives patients and healthcare providers another option for administering the treatment.
Yesintek® is used to treat a range of autoimmune conditions. Its approved indications include moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children aged six years and above. The medicine is also indicated for adults with moderate to severely active Crohn’s disease and ulcerative colitis.
The availability of a single-dose prefilled autoinjector is expected to provide greater flexibility in treatment and support different patient and care settings. The device-based format is designed to offer a convenient option for patients requiring ongoing treatment for chronic autoimmune diseases.
The latest US FDA approval strengthens Biocon’s immunology portfolio in the United States. The company said the approval reflects its focus on expanding access to affordable medicines for patients. Biocon has been expanding its presence in the global biosimilars and complex medicines market, with immunology forming an important part of its portfolio. The addition of the Yesintek autoinjector presentation provides another dosage and delivery option for patients using ustekinumab-based treatment.
The product addresses diseases that can have a significant impact on patients’ daily lives. Plaque psoriasis can cause persistent skin lesions, while psoriatic arthritis can affect joints and movement. Crohn’s disease and ulcerative colitis are chronic inflammatory bowel diseases that can require long-term treatment and monitoring.
With the supplemental approval, Yesintek is now available in the United States in additional single-dose autoinjector presentations. The 45 mg/0.5 ml and 90 mg/ml formats broaden the available delivery options for eligible patients. Biocon said the development supports its efforts to make important therapies more accessible and strengthen its presence in the US market. The company continues to build its portfolio of affordable medicines across major therapeutic areas.
The latest approval also adds to Biocon’s range of products in immunology and provides patients with another treatment format for conditions requiring long-term care. The company expects the expanded Yesintek offering to support healthcare providers and patients seeking convenient treatment options across different care settings.
