Celltrion’s Steqeyma Approved as Stelara Biosimilar for Psoriasis

The US Food and Drug Administration (FDA) has approved Celltrion’s Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), for the treatment of several immune-mediated diseases.

Steqeyma joins the growing list of Stelara biosimilars and is the seventh to gain FDA approval, following Biocon Biologics’ Yesintek (ustekinumab-kfce).

Related: FDA Approves Dong-A ST’s Imuldosa (Ustekinumab), a Stelara Biosimilar

Designed to treat adults and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adults with Crohn’s disease and ulcerative colitis, Steqeyma offers patients an alternative to the reference biologic, Stelara, with comparable safety, purity and potency.

Steqeyma was evaluated through a comprehensive set of studies, including a Phase III trial that showed that the biosimilar met the primary endpoint of improved Psoriasis Area and Severity Index (PASI) scores by Week 12 and sustained results through Week 28. Safety results were also strong, with low rates of side effects and no serious issues that led to stopping treatment.

Importantly, patients switching from Stelara to Steqeyma maintained stable anti-drug antibody (ADA) levels, demonstrating consistent immune responses to the drug over time.

These results support Steqeyma’s approval for use in subcutaneous injections and intravenous infusions, providing patients with flexible administration options.

As a biosimilar, Steqeyma replicates the structure and function of ustekinumab, a monoclonal antibody that targets interleukin-12 (IL-12) and interleukin-23 (IL-23) — key cytokines involved in immune-mediated diseases. By blocking these inflammatory pathways, it helps manage overactive immune responses in conditions like psoriasis and Crohn’s disease.

Expanding Celltrion’s immunology portfolio, Steqeyma is expected to launch in the US by February 2025. It will join other innovative treatments by Celltrion, including Zymfentra (infliximab-dyyb) and CT-P55, an investigational biosimilar to Novartis’ Cosentyx (secukinumab), currently in Phase III trials.

Since September 2024, a new Stelara biosimilar has been approved nearly every month, reflecting a rapid shift in the global biosimilar market. This trend is projected to continue, with the psoriasis biosimilars market expected to reach approximately $26.7 billion by 2034, driven by an 11.2 percent compound annual growth rate (CAGR).

Biosimilars are reshaping the biologics market by driving competition and affordability. Stelara, which generated $6.97 billion in US sales in 2023, was included in Medicare’s price negotiation list, reducing its 30-day supply cost to $4,695 starting January 2026 — a 66 percent drop from its 2023 list price of $13,836.

The anticipated launch of Steqeyma and Imuldosa (ustekinumab-srlf) in early 2025 has the potential to further influence pricing.

With the approval of Steqeyma, Celltrion aims to improve patient access to biologic therapies while reducing treatment costs, with plans to closely monitor Steqeyma’s real-world performance post-launch.