Strategic Milestone: Biocon Secures Worldwide Entry for YESINTEK
Clinical studies showed that Yesintek is a biosimilar to Stelara and has similar pharmacokinetic, safety, efficacy and immunogenicity profile compared with Stelara. Yesintek received the US FDA approval in December 2024.
Biocon Ltd said its subsidiary Biocon Biologics has secured multiple market access agreements for Yesintek, its biosimilar to Stelara. The market access agreements from numerous plans represent over 100 million lives in the US.
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. United Healthcare 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, Biocon said in an exchange filing.
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 Stelara.
The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial.
Clinical studies showed that Yesintek is a biosimilar to Stelara and has similar pharmacokinetic, safety, efficacy and immunogenicity profile compared with Stelara.
Yesintek received the US Food and Drug Administration (FDA) approval in December 2024.
“Yesintek 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 listing of Yesintek on multiple formularies is another validation that payors in the US are committed to broaden access to affordable treatment options,” said Shreehas Tambe, CEO & Managing Director at Biocon Biologics.
Josh Salsi, Head of North America at Biocon Biologics said that over 100 million Americans — representing 70%-80% of the commercial market — are now covered for Yesintek through commercial formularies.
Shares of Biocon Ltd. ended 1.06% lower on Friday at Rs 318.40. The stock has fallen 14% so far in 2025.
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