MUMBAI:  Biocon Biologics Ltd has announced the US launch of Yesintek  (ustekinumab-kfce), one of the first biosimilars to Janssen's Stelara® to enter the American market.

The biosimilar, approved by the US Food and Drug Administration in December 2024, is indicated for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Yesintek will be available in all formulations currently offered by the reference product.

Biocon Biologics chief executive officer & managing director Shreehas Tambe called the launch "a significant step in our commitment to improving the lives of patients with inflammatory conditions" and noted it represents the company's first US product launch since becoming a fully integrated global biosimilars organisation.

The monoclonal antibody disrupts IL-12 and IL-23 mediated signalling associated with immune-mediated diseases. Clinical studies demonstrated Yesintek has similar pharmacokinetic, safety, efficacy and immunogenicity profiles compared with Stelara®.

Crohn's & Colitis Foundation chief education, support and advocacy officer  Laura Wingate  described the launch as "a meaningful advancement for eligible chronic disease patients, who now have more treatment options available."

Biocon confirmed Yesintek will have commercial payer coverage at launch alongside a patient assistance programme that includes benefits verification and copay support, with eligible patients potentially paying as little as $0.

Josh Salsi, head of North America at Biocon Biologics Inc, emphasised that healthcare providers switching to Yesintek can expect "a seamless treatment experience covering the same indications and dosing options."