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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 will be 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.
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Shreehas Tambe, CEO and Managing Director of Biocon Biologics Ltd said, “The launch of YESINTEK marks a significant step in our commitment to improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars. It also represents our first product launch in the United States since becoming a fully integrated global biosimilars organization.”
YESINTEK will have commercial payor coverage at launch and also have a robust patient assistance program that includes benefits verification, copay support, among other services. The copay program is competitive with the originator offering and eligible patients who meet the program criteria may
pay as little as $0.
Laura Wingate, Chief Education, Support & Advocacy Officer of the Crohn’s & Colitis Foundation, said: “The burden of Crohn’s disease and ulcerative colitis on patients’ daily lives is substantial. This is a meaningful advancement for eligible chronic disease patients, who now have more treatment
options available.”
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YESINTEK is a monoclonal antibody that disrupts IL-12 and IL-23 mediated signaling-associated immune-mediated diseases. Clinical studies showed that YESINTEK is a biosimilar to Stelara and has similar pharmacokinetic, safety, efficacy and immunogenicity profiles compared with Stelara. YESINTEK received US Food and Drug Administration (FDA) approval in December 2024.
Shares of Biocon Ltd ended at ₹321.30, down by ₹0.75, or 0.23% on the BSE.
First Published: Feb 24, 2025 5:54 PM IST
