Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., has announced that the company has secured multiple market access agreements for Yesintek (ustekinumab-kfce), its biosimilar to Stelara (ustekinumab). The market access agreements from numerous plans represent over 100+ million lives in the United States.

Express Scripts has added YESINTEK to the National Preferred Formulary (NPF) effective March 21, 2025. Cigna has added YESINTEK to its commercial formulary beginning on March 21, 2025. UnitedHealthcare has added YESINTEK to several formularies including commercial beginning May 1, 2025; managed Medicaid beginning March 1, 2025; and Medicare beginning June 1, 2025. CVS Health has added YESINTEK beginning July 1, 2025. And finally, Optum Rx has added YESINTEK to its Premium and Select formularies beginning July 1, 2025.

YESINTEK has also been selected on several other formularies, including Navitus, Costco Health Solutions, MedImpact, Priority Health, University of Pittsburgh Medical Center (UPMC), and several other regional health plans. Additionally, YESINTEK has been selected as the exclusive Ustekinumab by Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and several closed-door health systems.

The company is also finalising formulary agreements with other commercial carriers.

Shreehas Tambe, CEO and Managing Director, Biocon Biologics Ltd., said, “Yesintek (Ustekinumab kfce) represents an important milestone for Biocon Biologics, as this is the first product we have launched in the United States as a fully integrated biosimilars company. The strong adoption of Yesintek by payors in the US reflects their confidence in our science, supply reliability, and commercial capability. The listing of Yesintek on multiple formularies is another validation that payors in the US are committed to broaden access to affordable treatment options.”

Josh Salsi, Head of North America, Biocon Biologics Inc., said, “More than 100 million Americans representing 70-80 percent of the commercial market are now covered for Yesintek (ustekinumab-kfce) through commercial formularies. This marks a significant step forward in bringing high-quality, affordable biosimilars to patients managing chronic conditions.”

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 is available in all the same formulations currently provided by STELERA. The available presentations are 45 mg/0.5 mL PFS, 90 me/mL PFS. 45 mg/0.5 mL vial, and 130 mg/26 mL vial.

YESINTEK is a monoclonal antibody that disrupts IL-12 and IL-23 mediated signalling associated immune mediated diseases. Clinical studies showed that YESINTEK is a biosimilar to STELERA and has similar pharmacokinetic, safety, efficacy and immunogenicity profile compared with STELERA. YESINTEK received US Food and Drug Administration (FDA) approval in December 2024.