Biocon Ltd. said on May 5, 2025, that its unit Biocon Biologics has obtained several market access deals in the United States for Yesintek, a biosimilar to Stelara. Collectively, the deals offer coverage for more than 100 million lives across several U.S. healthcare plans, effectively broadening patient access.
Yesintek has been added to Express Scripts’ National Preferred Formulary (NPF), effective March 21, 2025. Cigna has added Yesintek to commercial formulary as of March 21, 2025.
United Healthcare has added Yesintek to commercial plans from May 1, 2025, in managed Medicaid from March 1, 2025, and in Medicare from June 1, 2025.
CVS Health will start listing Yesintek on and after July 1, 2025. Optum Rx has added Yesintek to its Premium and Select formularies on and after July 1, 2025. Yesintek is further listed by multiple other pharmacy benefit managers and health plans such as Navitus, Costco Health Solutions, MedImpact, Priority Health, and University of Pittsburgh Medical Center (UPMC), etc.
The drug has been chosen as the sole ustekinumab by Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and other closed-door health systems.
Biocon Biologics is finalizing more formulary agreements with other U.S. commercial healthcare carriers. Yesintek is indicated for the treatment of chronic autoimmune diseases like Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. It is supplied in the same presentations as Stelara, i.e., 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial.
Clinical trials had established that Yesintek is comparable to Stelara in terms of pharmacokinetics, safety, efficacy, and immunogenicity. Yesintek was approved by the U.S. FDA in December 2024. This is Biocon Biologics’ inaugural launch of a product in the U.S. as a complete biosimilars organization.
As per Biocon Biologics’ CEO & MD Shreehas Tambe, the broad listing of Yesintek is a key endorsement of the company’s initiatives towards increasing access to cost-effective treatment alternatives.
Josh Salsi, North America Head at Biocon Biologics, pointed out that the biosimilar is now reimbursed for 70%–80% of the commercial market in the U.S., reflecting good acceptance and coverage.
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