Biocon Biologics Ltd. (BBL), a leading global biosimilars company and a subsidiary of Biocon Ltd., has announced the availability of YESINTEK™ (ustekinumab-kfce) in the United States. As one of the first biosimilars to Stelara® (ustekinumab) in the country, YESINTEK offers a more cost-effective treatment option for patients with chronic autoimmune diseases. It is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
Patients will have access to YESINTEK in all the same formulations as the reference biologic, including prefilled syringes and vials in multiple strengths. The biosimilar has secured commercial payor coverage at launch and comes with a comprehensive patient assistance program. Eligible patients may benefit from copay support, with some paying as little as $0, making the treatment more affordable.
YESINTEK is a monoclonal antibody that disrupts IL-12 and IL-23 mediated signaling, which plays a key role in immune-mediated diseases. Clinical studies have confirmed its similarity to Stelara® in terms of pharmacokinetics, safety, efficacy, and immunogenicity. The U.S. Food and Drug Administration (FDA) approved YESINTEK in December 2024, reinforcing its credibility as a reliable biosimilar.
Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd., stated, “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.”
