Biocon Biologics launches YESINTEK, a Stelara biosimilar, in the United States

Biocon Biologics, a subsidiary of Biocon and a global biosimilars company, has announced the US launch of YESINTEK (ustekinumab-kfce), one of the first Stelara (ustekinumab) biosimilars available in the country.

YESINTEK has received approval for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The biosimilar aims to increase patient access to cost-effective treatment options for chronic autoimmune diseases. It will be available in the same formulations and presentations as Stelara, including 45 mg/0.5 mL pre-filled syringe (PFS), 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial.

Shreehas Tambe, CEO and Managing Director of Biocon Biologics, stated, “The launch of YESINTEK marks a significant step in our commitment to improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars. It also represents our first product launch in the United States since becoming a fully integrated global biosimilars organization. We are excited to be among the first companies to introduce a high-quality, affordable biosimilar Ustekinumab to this patient population.”

Laura Wingate, Chief Education, Support and Advocacy Officer of the Crohn’s & Colitis Foundation, said, “The burden of Crohn’s disease and ulcerative colitis on patients’ daily lives is substantial. This is a meaningful advancement for eligible chronic disease patients, who now have more treatment options available.”

Biocon Biologics has confirmed that YESINTEK will have commercial payor coverage at launch, supported by a patient assistance programme. This will include benefits verification, copay support, and other services. The copay programme is positioned competitively with the originator’s offering, with eligible patients potentially paying as little as $0, depending on programme criteria.

YESINTEK is a monoclonal antibody that targets interleukin-12 (IL-12) and interleukin-23 (IL-23) mediated signalling pathways, which are associated with immune-mediated diseases. Clinical trials have demonstrated that YESINTEK has similar pharmacokinetics, safety, efficacy, and immunogenicity profiles when compared to Stelara. The US Food and Drug Administration (FDA) approved YESINTEK in December 2024.

Josh Salsi, Head of North America at Biocon Biologics, concluded, “For healthcare providers, switching to YESINTEK offers a seamless treatment experience covering the same indications and dosing options. Patients can feel confident that YESINTEK comes from Biocon Biologics, a company with extensive biosimilar expertise in immunology.”