Biocon Biologics’ Stelara Biosimilar Performs Well in Phase 3 Plaque PsO Study

 Yesintek, Biocon Biologics’ ustekinumab biosimilar, demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics with reference product Stelara (ustekinumab) in adults with moderate-to-severe chronic plaque psoriasis (PsO).

The data were presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

The primary efficacy endpoint, percentage change from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12, demonstrated that Yesintek was equivalent to reference Stelara (Ustekinumab), with both treatments showing similar improvement in PASI scores. The mean difference between the two groups was 0.68%, falling within the predefined equivalence margins for both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The safety profile of Yesintek was similar to the reference product, Stelara, throughout the study.

The pharmacokinetic and immunogenicity profiles of Yesintek were similar to those of reference Stelara, with no significant differences in efficacy or safety outcomes between the two treatments. Additionally, the study assessed the impact of switching from reference Stelara to Yesintek at Week 16, with results showing continued efficacy and safety through Week 52.

“The positive results from this Phase 3 study reaffirm the quality and therapeutic equivalence of YESINTEK compared to reference product ustekinumab. This milestone underscores our commitment to providing cost-effective, high-quality biosimilars to patients with chronic conditions like psoriasis, expanding access to critical treatments globally,” says Elena Wolff-Holz, MD, Global Head of Clinical Development at Biocon Biologics in a news release.

“The study reinforces the confidence we can have in the biosimilar regulatory pathways and the principles they are built on. Specifically, for YESINTEK, the study shows that it offers an effective, safe, and comparable alternative to reference Ustekinumab in the treatment of moderate to severe chronic plaque psoriasis and, by extension, the other indications for which Ustekinumab is indicated,” adds Uwe Gudat, MD, Chief Medical Officer at Biocon Biologics. “YESINTEK is another important addition to our portfolio of affordable biologics that promise improved patient care by providing a cost-effective treatment option without compromising clinical outcomes.”

Celltrion Launches Stelara Biosimilar in the U.S

Celltrion is launching Steqeyma (ustekinumab-stba), a biosimilar to Stelara in the U.S., following approval by the FDA in December 2024.

Steqeyma is approved for the same indications as Stelara, namely plaque psoriasis (PsO) and psoriatic arthritis (PsA) in adult and pediatric patients, as well as Crohn’s disease (CD) and ulcerative colitis (UC) in adult patients. It is available in both subcutaneous injection and intravenous infusion.

“Chronic inflammatory diseases such as plaque psoriasis and psoriatic arthritis place significant burden on patients,” says Mark G. Lebwohl, MD,MD, Dean of Clinical Therapeutics at the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, in New York City, in a news release. “Biosimilars increase access to essential therapies while maintaining the same high standards as the reference product. The availability of STEQEYMA provides patients and healthcare providers a cost-effective alternative to manage chronic inflammatory diseases.”

Steqeyma will be priced with a Wholesale Acquisition Cost (WAC) list price at an 85% discount to the current WAC list price of Stelara to help improve patient access to high-quality biologic treatments.

“The introduction of STEQEYMA in the U.S., as one of the first-wave biosimilars to STELARA, marks an important step in our ongoing efforts to expand patient access to high-quality biologic treatments,” says Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “With this launch, we are expanding our immunology portfolio beyond TNF-alpha to include IL-12/23 inhibitors, offering more options for multiple immune-mediated diseases. To further enhance accessibility, Celltrion is actively collaborating with key pharmacy benefit managers to secure broader formulary coverage for STEQEYMA.”

Steqeyma is supported by Celltrion’s comprehensive patient and practice support programs, designed to assist patients throughout their treatment journey. Celltrion offers a suite of resources, including Celltrion CONNECT Patient Support Program and Celltrion CARES Co-pay Assistance Program, benefits verification, prior authorization assistance, and co-pay assistance. Eligible patients with private or commercial insurance may pay as little as $0 out of pocket per dose. Uninsured patients may be eligible to receive STEQEYMA through the Celltrion CONNECT Patient Assistance Program (PAP). Additionally, nurses will be available to answer patient questions and provide injection support. Visit www.CelltrionConnect.com to learn more.