New Delhi: Biocon Ltd on Monday said its arm Biocon Biologics Ltd has secured multiple market access agreements in the US for its biosimlar, Yesintek, that has been approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Yesintek (ustekinumab-kfce), is biosimilar to Stelara (ustekinumab).
"The market access agreements from numerous plans represent over 100 million lives in the United States," Biocon said in a regulatory filing.
"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," Biocon Biologics CEO & Managing Director Shreehas Tambe said.
He further said,"the strong adoption of Yesintek... in the US 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 US are committed to broaden access to affordable treatment options."
Biocon Biologics said Express Scripts has added Yesintek to the National Preferred Formulary (NPF) effective March 21, 2025, while Cigna has added the biosimilar to its commercial formulary beginning on March 21, 2025.
Similarly, 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 and Optum Rx have added Yesintek to their premium and select formularies beginning July 1, 2025.
The company further said 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, it has been selected as the exclusive Ustekinumab by Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and several closed-door health systems, it added.
"The company is also finalising formulary agreements with other commercial carriers," it added.
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, Biocon Biologics said.
It is available in all the same formulations currently provided by STELERA in presentations of 45 mg/0.5 mL PFS, 90 mg/mL PFS (prefilled syringe), 45 mg/0.5 mL vial, and 130 mg/26 mL vial, it added.
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"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," Biocon Biologics CEO & Managing Director Shreehas Tambe said.
He further said,"the strong adoption of Yesintek... in the US 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 US are committed to broaden access to affordable treatment options."
Biocon Biologics said Express Scripts has added Yesintek to the National Preferred Formulary (NPF) effective March 21, 2025, while Cigna has added the biosimilar to its commercial formulary beginning on March 21, 2025.
Similarly, 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 and Optum Rx have added Yesintek to their premium and select formularies beginning July 1, 2025.
The company further said 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, it has been selected as the exclusive Ustekinumab by Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and several closed-door health systems, it added.
"The company is also finalising formulary agreements with other commercial carriers," it added.
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, Biocon Biologics said.
It is available in all the same formulations currently provided by STELERA in presentations of 45 mg/0.5 mL PFS, 90 mg/mL PFS (prefilled syringe), 45 mg/0.5 mL vial, and 130 mg/26 mL vial, it added.