Biocon Biologics Introduces Yesintek Biosimilar to Stelara in US

BRIDGEWATER, N.J. and BENGALURU, India, Feb. 24, 2025 - Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., has announced the launch of YESINTEK™ (ustekinumab-kfce) in the United States. This biosimilar marks one of the initial market entries to rival Stelara® (ustekinumab), offering a more affordable option for patients. YESINTEK is approved for treating various chronic autoimmune conditions, including Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The launch is significant as it enhances patient access to cost-effective treatments, ensuring availability in all formulations similar to Stelara, such as 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial.

Biocon Biologics’ CEO, Shreehas Tambe, expressed that launching YESINTEK in the United States is a crucial step in expanding the company's presence in the biosimilar market, particularly for inflammatory conditions. This launch underscores their commitment to providing high-quality and affordable biosimilars globally. Laura Wingate from the Crohn's & Colitis Foundation highlighted the impact of chronic diseases like Crohn’s and ulcerative colitis on patients and noted the importance of having more treatment options that YESINTEK offers.

Upon its introduction, YESINTEK will have commercial payor coverage and a comprehensive patient assistance program. These programs include benefits verification and copay support, allowing eligible patients to potentially pay as little as $0. The copay setup is competitive with the originator’s offer, ensuring accessibility for patients needing financial assistance.

YESINTEK is a monoclonal antibody targeting IL-12 and IL-23 mediated pathways, addressing immune-mediated diseases. Clinical studies confirm its equivalence to Stelara in terms of pharmacokinetics, safety, efficacy, and immunogenicity. It gained FDA approval in December 2024, following extensive analysis and successful clinical trials such as the Phase 3 STELLAR-2 Study. This study verified no significant differences between YESINTEK and Stelara in treating moderate-to-severe plaque psoriasis.

For healthcare providers, the transition to YESINTEK will be seamless, covering the same treatment indications and dosages as Stelara. This ensures continuity and reliability in patient care, backed by Biocon Biologics’ expertise in immunology. Josh Salsi, Head of North America for Biocon Biologics Inc., emphasized that patients and healthcare providers can trust in the quality and efficacy of YESINTEK given the company's extensive background in biosimilars.

YESINTEK is specifically indicated for various conditions, including moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn’s disease and ulcerative colitis in adults. It is also suitable for pediatric patients aged six and older with similar conditions. However, it carries contraindications for individuals with hypersensitivity to ustekinumab or its excipients.

The medication comes with essential precautions, such as avoiding its initiation during active infections and ensuring patients are screened for tuberculosis before treatment. Patients should also be cautious about receiving live vaccines during treatment. Additionally, there are warnings about potential serious infections, malignancies, hypersensitivity reactions, and noninfectious pneumonia, all of which require vigilance and appropriate management if they occur.

Biocon Biologics Ltd. stands as a global leader in biosimilars, leveraging advanced technology and innovation to make healthcare accessible through high-quality, affordable biologics. With a strong portfolio and ongoing developments across various medical fields, the company continues to impact patient care positively.