Toronto, ON – Celltrion has received approval from Health Canada for an auto-injector (AI) formulation of Steqeyma (ustekinumab), a biosimilar to Johnson & Johnson’s Stelara, expanding treatment options for patients with plaque psoriasis, psoriatic arthritis, and Crohn’s disease. The approval, announced Wednesday, marks the first time this particular delivery method will be available for ustekinumab in Canada, offering a more convenient alternative to traditional injections or infusions.
The addition of the 45mg/0.5mL and 90mg/1.0mL AI formulations completes Celltrion’s “full lineup” of Steqeyma products in the Canadian market, according to the company. This development comes as demand for self-administered injectable medications continues to grow globally, driven by a desire for increased patient convenience and reduced reliance on frequent healthcare visits.
Steqeyma’s approval in Canada builds on its growing presence in North America. The drug, a monoclonal antibody, received Health Canada approval in July 2024. According to Celltrion, the auto-injector format is expected to improve treatment accessibility for patients who find frequent trips to medical facilities challenging, while also enhancing the safety and ease of self-administration. The company highlighted the potential for improved patient satisfaction with this recent delivery method.
The move to offer an auto-injector version of Steqeyma is particularly significant as it differentiates the biosimilar from the original Stelara product, which currently does not have an auto-injector option available in Canada. This distinction positions Steqeyma as a potentially attractive alternative for patients and healthcare providers seeking greater flexibility in treatment administration.
Expanding Market Access in North America
Celltrion is strategically targeting the North American market with Steqeyma, having already secured preferred formulary status with two of the three major Pharmacy Benefit Managers (PBMs) in the United States. This access translates to broader insurance coverage and increased patient access to the medication. According to market research firm IQVIA, Steqeyma held an 8.6% market share in the U.S. As of January 2026. Health Canada’s Drug and Health Products Portal provides further information on approved medications.
What is Steqeyma and How Does it Work?
Steqeyma is a biosimilar, meaning it is highly similar to the original Stelara but manufactured by a different company. Both medications target specific proteins in the body that contribute to inflammation, effectively managing symptoms associated with autoimmune diseases. Specifically, ustekinumab, the active ingredient in Steqeyma, is a monoclonal antibody that targets interleukin-12 and interleukin-23, key players in the inflammatory processes of psoriasis, psoriatic arthritis, and Crohn’s disease.
The approved indications for Steqeyma in Canada include:
- Plaque Psoriasis
- Psoriatic Arthritis
- Crohn’s Disease
The availability of multiple dosage strengths – 45mg/0.5mL, 90mg/1.0mL (subcutaneous injection), and 130mg/26ml (intravenous infusion) – allows for personalized treatment plans tailored to individual patient needs.
Celltrion’s Broader Biosimilar Portfolio
Steqeyma is part of Celltrion Healthcare’s growing portfolio of biosimilars. The company also markets Omlyclo, a biosimilar to omalizumab approved in Canada on December 6, 2024, for allergic asthma and chronic rhinosinusitis. Remsima SC, a subcutaneous formulation of infliximab, received Health Canada approval for rheumatoid arthritis in 2021 and for Crohn’s disease and ulcerative colitis in February 2024. Celltrion Healthcare’s website provides detailed product information.
Looking Ahead
Celltrion anticipates that the Canadian approval of Steqeyma’s auto-injector formulation will accelerate its market penetration in North America. The company plans to leverage its existing commercial infrastructure and favorable PBM contracts in the U.S. To drive further growth. The next key milestone for Celltrion will be monitoring the uptake of the auto-injector formulation in Canada and assessing its impact on overall Steqeyma sales.
This article provides information for general knowledge and informational purposes only, and does not constitute medical advice. It is essential to consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.
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