Biocon’s Yesintek Gains Major U.S. Market Access

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd, has made a significant advancement with its biosimilar Yesintek™ (ustekinumab-kfce).  

Yesintek is a biosimilar to Stelara® (ustekinumab) and has now secured market access agreements representing over 100 million lives in the United States.  

These agreements will significantly improve patient access to cost-effective treatments for chronic autoimmune diseases such as Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. 

Indications and FDA Approval 

Several prominent U.S. health plans have included Yesintek in their formularies, starting with Express Scripts, which added Yesintek to its National Preferred Formulary (NPF) effective March 21, 2025.  

Cigna also added Yesintek to its commercial formulary, effective from the same date. UnitedHealthcare will include Yesintek in its various formularies, such as commercial, managed Medicaid, and Medicare plans, starting from May 1, 2025, March 1, 2025, and June 1, 2025, respectively.  

CVS Health and Optum Rx will begin offering Yesintek starting July 1, 2025. In addition, Yesintek has been selected by several other regional health plans, including Navitus, Costco Health Solutions, and MedImpact. 

Yesintek has been FDA-approved since December 2024 for the treatment of chronic autoimmune diseases. It is available in multiple formulations, including 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial. Clinical studies have demonstrated that Yesintek is highly similar to Stelara, with comparable pharmacokinetic, safety, efficacy, and immunogenicity profiles. 

Management Commentary 

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said, “Yesintek™ (Ustekinumabkfce) 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 U.S. 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 U.S. are committed to broaden access to affordable treatment options.” 

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

Also Read: Biocon Board Greenlights Fundraising Plan of Up to ₹4,500 Crore!

Conclusion 

The broad formulary access and the potential for greater patient affordability mark an important step for Biocon Biologics in expanding its biosimilar portfolio, reinforcing its position in the global biosimilars market. 

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