Celltrion announced on March 20, 2026, that it has received additional approval from Health Canada for the autoinjector (AI) formulation of its autoimmune disease treatment, Steqeyma (active ingredient: ustekinumab). This regulatory milestone secures two specific AI strengths for the Canadian market: 45 mg/0.5 mL and 90 mg/1.0 mL.
Steqeyma is a biosimilar to Janssen’s Stelara. Notably, the approval of an autoinjector formulation provides Celltrion with a significant competitive advantage, as this specific delivery method is currently unavailable for the originator product in Canada. This allows Steqeyma to offer a "full lineup" that encompasses both various dosage strengths and diverse administration options.
The autoinjector is designed to improve treatment access for patients who have difficulty visiting medical facilities, offering enhanced safety and convenience for self-administration.
Celltrion intends to use this Canadian approval as a springboard to accelerate its broader North American strategy. As of January 2026, the Steqeyma product family held an estimated 8.6% share of the relevant market in the United States. Following its successful U.S. launch in early 2025, the company aims to leverage its comprehensive portfolio to capture further market share across the region.
"By securing an administration option in Canada that the originator product does not offer, we have strengthened Steqeyma’s market differentiation," a Celltrion official stated. "Leveraging our proven product competitiveness and the synergy of a full lineup, we will continue to lead the global ustekinumab market."
