In a press release datelined Bridgewater, New Jersey in the US, and Bengaluru 24 February 2025, Biocon Biologics a subsidiary of Biocon announced that its Yesintek is now available in the US as an alternative to Stelara.
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. It 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.
Shreehas Tambe, CEO and 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 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.”
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 that meet the program criteria may pay as little as $0.
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 profile compared with Stelara. Yesintek received US Food and Drug Administration (FDA) approval in December 2024.
Josh Salsi, Head of North America, Biocon Biologics, 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.”
For more information and resources, please visit www.yesintek.com. Health care professionals can access more information at www.yesintekHCP.com.
About YESINTEK
The approval for YESINTEK (ustekinumab-kfce) was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that YESINTEK is highly similar to Stelara®. In a Phase 3 STELLAR-2 Study, YESINTEK was compared with Stelara® in patients with moderate-to-severe chronic Plaque Psoriasis. The study demonstrated that there were no clinically meaningful differences between YESINTEK and Stelara in terms of pharmacokinetics, safety, efficacy, and immunogenicity.
