Biocon Limited’s US subsidiary has received supplemental approval from the US Food and Drug Administration (FDA) for two new single-dose prefilled autoinjector presentations of Yesintek, expanding the company’s treatment options for patients with chronic autoimmune diseases.

The FDA has approved Yesintek 45 mg/0.5 ml single-dose prefilled autoinjector and Yesintek 90 mg/ml single-dose prefilled autoinjector. Yesintek was originally approved by the US FDA on November 29, 2024.

The newly approved delivery formats are designed to provide patients with an additional treatment option and support more tailored approaches to treatment across different care settings and patient requirements.

Yesintek is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult and paediatric patients aged six years and older. It is also indicated for moderately to severely active Crohn’s disease and ulcerative colitis in adults.

The approval expands Biocon’s immunology portfolio in the US, where the company is focused on increasing access to affordable therapies for patients living with chronic and debilitating autoimmune conditions.

According to a company spokesperson, the supplemental approval strengthens Biocon’s comprehensive immunology portfolio in the US and reinforces its commitment to improving access to affordable medicines globally.