Biocon Biologics launches biosimilar alternative to Stelara in the US

Biocon Biologics, a subsidiary of Biocon, announced that YESINTEK (ustekinumab-kfce) is now available to patients in the United States, the company said in a statement on Monday. The launch marks a significant move, as YESINTEK is among the first biosimilar alternatives to Stelara (ustekinumab) to enter the US market.

 

YESINTEK is approved for Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, offering a cost-effective treatment for chronic autoimmune diseases. It will be available in the same formulations as Stelara, ensuring broader patient access to effective therapy options.

 

Shreehas Tambe, CEO & Managing Director, Biocon Biologics said, “The launch 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 US since becoming a fully integrated global biosimilar organisation.” bs reporter

 

We are excited to be among the first companies to introduce a high-quality, affordable biosimilar Ustekinumab to this patient population.”

 

YESINTEK will launch with commercial payor coverage and a comprehensive patient assistance program, including benefits verification, copay support, and competitive pricing, with eligible patients paying as little as $0.

 

YESINTEK is a monoclonal antibody disrupting IL-12 and IL-23 signaling in immune diseases. The biosimilar received FDA approval in December 2024 as a biosimilar to Stelara.

 

“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,” highlighted Josh Salsi, Head of North America, Biocon Biologics Inc.