Biocon gains after arm launches YESINTEK Biosimilar in U.S. Market

Biocon added 1.36% to Rs 325.25 after the company announced that its subsidiary, Biocon Biologics (BBL), has launched YESINTEK (ustekinumab-kfce) in the United States.

YESINTEK is a biosimilar to Stelara (ustekinumab) and is one of the first biosimilar versions of Stelara to be introduced to the U.S. market.

The biosimilar is approved for the treatment of Crohns 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.

At launch, YESINTEK will be covered by commercial payors and will also feature an extensive patient assistance program that includes benefits verification, copay support, and other services. The copay program is structured to be competitive with the originators offering, with eligible patients potentially paying as little as $0 based on program criteria.

A monoclonal antibody, YESINTEK targets IL-12 and IL-23-mediated signaling, which is linked to immune-mediated diseases. Clinical trials have demonstrated that YESINTEK is a biosimilar to Stelara, with comparable pharmacokinetic, safety, efficacy, and immunogenicity profiles. The biosimilar received approval from the U.S. Food and Drug Administration (FDA) in December 2024.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics, 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. We are excited to be among the first companies to introduce a high-quality, affordable biosimilar Ustekinumab to this patient population.

Laura Wingate, chief education, support & advocacy officer of the Crohns & Colitis Foundation, said: The burden of Crohns 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.

Josh Salsi, Head of North America, Biocon Biologics Inc., said: For healthcare providers, switching to YESINTEK offers a seamless treatment experience covering the same indications and dosing options. Patients can feel confident that YESINTEK comes from Biocon Biologics, a company with extensive biosimilar expertise in immunology.

Biocon is an innovation-led global biopharmaceuticals company engaged in the production of therapies for chronic conditions like diabetes, cancer, and autoimmune diseases. It has developed and commercialized novel biologics, biosimilars, and complex small-molecule APIs in India and several key global markets, as well as generic formulations in the US, Europe, & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.

The company had reported a consolidated net profit of Rs 25 crore in Q3 FY25, which is significantly lower as compared with the PAT of Rs 660 crore posted in Q3 FY24. Revenue from operations fell by 3% YoY to Rs 3,821 crore during the period under review.

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