Stelara Biosimilar Yesintek Gains Coverage on Leading Formularies

Biocon Biologics’s Yesintek (ustekinumab-kfce) has secured access on several major plans and formularies that cover in total more than 100 million lives. Plan/PBM coverage includes:

• 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.
• 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.

Related: MedImpact Adds the Biosimilars Selarsdi and Yesintek to Formulary

In most cases, Yesintek is covered alongside Stelara and on the same tier. Prior authorization requirements vary by plan and formulary. A Biocon Biologics spokesperson told Formulary Watch they are unable to provide more detailed information regarding Yesintek’s coverage by specific plans or PBMs. The spokesperson said that in some cases, Stelara will be removed from formularies, with the timing varying by plan and formulary, with many expected by the end of the year.

“More than 100 million Americans — representing 70% to 80% of the commercial market — are now covered for Yesintek through commercial formularies, Josh Salsi, head of North America, Biocon Biologics, said in a news release.

Stelara and its biosimilars treat patients with psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and pediatric psoriatic arthritis. Ustekinumab and its biosimilars are human monoclonal antibodies (mAb) that selectively target the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases.

Stelara, developed by Johnson & Johnson, was originally approved by the FDA in 2009 for the treatment of adults with moderate to severe psoriasis. Stelara has a list price of $25,497.12 every 8 weeks for the 90 mg dose. In 2023, it generated $10.86 billion in global revenue, compared with $6.4 billion in 2022. In 2024, sales of Stelara declined 13.6% because of anticipated biosimilar competition, J&J executives said in an investor call.

Seven biosimilars that reference Stelara have been approved. In addition to Yesintek, five others have launched: Teva/Alvotech’s Selarsdi (at an 85% discount off Stelara); Amgen’s Wezlana (only available through Optum Rx with both a high- and low-list price); Celltrion’s Steqeyma (at an 85% discount); Fresenius Kabi’s Otulfi; and Sandoz’ Pyzchiva (at an 80% discount).

Yesintek has a wholesale acquisition cost (WAC) of approximately $3,000, reflecting about a 90% discount compared with Stelara’s WAC.