Biocon Biologics Ltd. (BBL), a global biosimilars company and subsidiary of Biocon Ltd., has announced that its biosimilar Yesintek™ (ustekinumab-kfce), approved by the U.S. Food and Drug Administration (FDA) in December 2024, has gained significant market access agreements in the United States. Yesintek is a biosimilar to Stelara® (ustekinumab) and is indicated for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
Effective March 21, 2025, Express Scripts has added Yesintek to its National Preferred Formulary (NPF), and Cigna has included it in its commercial formulary. UnitedHealthcare has added Yesintek to its commercial formulary beginning May 1, 2025, as well as to its managed Medicaid formulary from March 1, 2025, and Medicare formulary starting June 1, 2025. CVS Health and Optum Rx will include the biosimilar beginning July 1, 2025, in various formulary categories, including Premium and Select.
In addition to these national pharmacy benefit managers and insurers, Yesintek has been selected for use by a number of regional and specialized formularies. These include Navitus, Costco Health Solutions, MedImpact, Priority Health, and the University of Pittsburgh Medical Center (UPMC). Certain closed health systems and payers, such as Blue Cross Blue Shield of Michigan (BCBSM) and Florida Healthcare Plan, have also opted to list Yesintek as their exclusive ustekinumab product.
Yesintek is offered in the same dosage forms as its reference product Stelara, including 45 mg/0.5 mL prefilled syringe, 90 mg/mL prefilled syringe, 45 mg/0.5 mL vial, and 130 mg/26 mL vial. It is a monoclonal antibody that targets interleukin-12 and interleukin-23, cytokines involved in the inflammatory response in autoimmune conditions. Clinical studies have demonstrated that Yesintek matches Stelara in pharmacokinetics, safety, efficacy, and immunogenicity.
