FDA Approves Steqeyma and Yesintek: Expanding Biosimilar Options for Stelara
Key Insights
The FDA has approved Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce) as biosimilars to Stelara, offering new options for patients with autoimmune and inflammatory conditions.
Steqeyma and Yesintek are approved for plaque psoriasis (search), psoriatic arthritis (search), Crohn's disease (search), and ulcerative colitis (search), mirroring Stelara's indications.
These approvals are expected to increase market competition and reduce treatment costs, with launches anticipated in early 2025 following licensing agreements.
The FDA has recently approved two new biosimilars for Stelara (ustekinumab): Steqeyma (ustekinumab-stba) by Celltrion and Yesintek (ustekinumab-kfce) by Biocon Biologics (search). These approvals mark a significant step forward in expanding treatment options and potentially reducing costs for patients suffering from autoimmune and inflammatory conditions.
Steqeyma and Yesintek are both approved for the treatment of moderate to severe plaque psoriasis (search) in adults and children, active psoriatic arthritis (search) in adults and children, moderately to severely active Crohn's disease (search) in adults, and moderately to severely active ulcerative colitis (search) in adults. These indications mirror those of the reference product, Stelara, offering patients and healthcare providers a range of treatment choices.
Clinical Equivalence and Safety
The FDA approvals were based on comprehensive data packages, including Phase 3 clinical trials, demonstrating that Steqeyma and Yesintek are highly similar to Stelara in terms of safety, efficacy, immunogenicity, and pharmacokinetics. For example, a Phase 3 study evaluating Yesintek in patients with moderate to severe chronic plaque psoriasis (search) showed equivalent efficacy to Stelara based on the Psoriasis Area and Severity Index (PASI) score. Specifically, the mean percent improvement in PASI score was 77.93% for Yesintek and 75.89% for Stelara.
Market Impact and Availability
With the entry of these biosimilars, the market is poised for increased competition, potentially driving down the cost of ustekinumab treatments. Stelara, a high-cost drug with a list price of $13,836 for a one-month supply, generated $10.86 billion in global revenue in 2023. The availability of biosimilars like Steqeyma and Yesintek is expected to alleviate the financial burden on patients and healthcare systems.
Celltrion anticipates launching Steqeyma in the U.S. in February 2025, while Biocon Biologics (search) plans to commercialize Yesintek no later than February 22, 2025, according to settlement and licensing agreements with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson.
Mechanism of Action
Ustekinumab, the active ingredient in Stelara, Steqeyma, and Yesintek, is a fully human monoclonal antibody that selectively inhibits interleukin (IL)-12 and IL-23 (search). These cytokines play a crucial role in inflammatory and immune responses, making ustekinumab an effective treatment for immune-mediated diseases.
Adverse Reactions and Contraindications
As with Stelara, Steqeyma and Yesintek carry warnings and precautions regarding the risk of serious infections, malignancies, hypersensitivity reactions, and posterior reversible encephalopathy syndrome (PRES). Common adverse reactions reported in clinical trials include nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
Expert Commentary
"The approval of STEQEYMA reflects Celltrion's continued investment in providing treatment options to patients diagnosed with ulcerative colitis (search), Crohn's disease (search), psoriasis, and psoriatic arthritis (search)," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. Mark G. Lebwohl, MD, Icahn School of Medicine at Mount Sinai, New York, added, "The approval of new treatment option is welcome news for people living with certain chronic inflammatory conditions, such as psoriasis, which affect more than 3% of the US adult population."