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Biocon Biologics secures multiple market access coverage for Yesintek in US

Biocon Biologics, a subsidiary of Biocon, on Monday said that it has secured multiple market access agreements for Yesintek in the US, its biosimilar which resembles the properties of Stelara. Clinical trials confirmed that Yesintek demonstrated comparable pharmacokinetics, safety, efficacy, and immunogenicity. A biosimilar is a biological medicine that is highly similar to an already approved biological medicine, also known as the reference product. Pharmacy benefit management firms like US-based Express Script have added Yesintek to the National Preferred Formulary (NPF) effective March 21. US healthcare multinational Cigna has also added Yesintek to its commercial formulary beginning on March 21. Yesintek has been approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, offering patients more affordable options for managing these common chronic autoimmune conditions. It is available in the same formulations as Stelara. 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. The available dosages include 45 mg/0.5 mL prefilled syringe, 90 mg/mL prefilled syringe, 45 mg/0.5 mL vial, and 130 mg/26 mL vial. The US Food and Drug Administration (FDA) approved Yesintek 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 broadening access to affordable treatment options,' said Shreehas Tambe, CEO & managing director at Biocon Biologics. Josh Salsi, head of North America at Biocon Biologics said, over 100 million Americans – representing 70 to 80 per cent of the commercial market – are now covered for Yesintek through commercial formularies.