Biocon Biologics unveils Yesintek biosimilar to Stelara in US

Bengaluru: BioconBiologics Ltd, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., has announced that YESINTEK (ustekinumab-kfce) is now available to patients in the United States.

The product is one of the first Stelara (ustekinumab) biosimilar market entrants in the country, claimed company.

YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, increasing patient access to more cost-effective treatment options for use in the treatment of common chronic autoimmune diseases.

YESINTEK will be available in all the same formulations currently provided by Stelara. The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said, “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 & 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.”

YESINTEK will have commercial payor coverage at launch and also have a robust patient assistance program that includes benefits verification, copay support, among other services. The copay program is competitive with the originator offering and eligible patients that meet the program criteria may pay as little as $0.

YESINTEK is a monoclonal antibody that disrupts IL-12 and IL-23 mediated signaling associated immune mediated diseases. Clinical studies showed that YESINTEK is a biosimilar to Stelara and has similar pharmacokinetic, safety, efficacy and immunogenicity profile compared with Stelara.

YESINTEK received U.S. Food and Drug Administration (FDA) approval in December 2024.

Josh Salsi, Head of North America, Biocon Biologics Inc., said, “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.”