Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd.  today announced that YESINTEK™ is now available to patients in the United States, and is one of the first Stelara® (ustekinumab) biosimilar market entrants in the country.

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.

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 U.S. Food and Drug Administration (FDA) approval in December 2024.

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."

The approval for YESINTEK 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.

Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes.

Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 12 biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website www.bioconbiologics.com; Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates.

 

Source: prnewswire.com

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