Celltrion has completed a full lineup of its auto-injector formulation for Steqeyma (STEQEYMA, active ingredient: ustekinumab) in Canada, accelerating its strategy to penetrate the North American autoimmune disease treatment market.
Celltrion announced on Friday that it has received additional approval from Health Canada for the auto-injector formulation of its autoimmune disease treatment, Steqeyma.
With this approval, Celltrion has secured two additional auto-injector formulations of Steqeyma in Canada: 45 mg/0.5 mL and 90 mg/1.0 mL.
This completes Celltrion’s full lineup of dosages and formulations, offering local patients a wider range of treatment options.
Notably, by obtaining an auto-injector formulation not available among original drugs in Canada, Celltrion has significantly enhanced its product competitiveness.
This approval is expected to further accelerate Steqeyma’s market penetration in North America. Previously, Steqeyma was listed as a preferred drug in the formularies of two major pharmacy benefit managers (PBMs) in the U.S., establishing reimbursement coverage.
As of January, Steqeyma held an 8.6% market share in the U.S. ustekinumab market. Following its market establishment in the U.S., Celltrion plans to leverage its Canadian full lineup to replace the demand for original drugs across North America.
Recently, demand for self-injection formulations has increased in major global markets, with auto-injector formulations gaining popularity due to their convenience for patient self-administration.
Celltrion expects that expanding these formulations will improve treatment accessibility for patients who find it difficult to visit healthcare facilities, while enhancing administration convenience and safety.
Additionally, Celltrion is strengthening its position in the autoimmune disease market by expanding its portfolio to include interleukin (IL) inhibitors like Steqeyma, complementing its existing TNF-α inhibitor products such as Remsima, Remsima SC, and Uplizna. The company plans to leverage synergies with its established product lineup in Canada to increase market share.
The global ustekinumab market is shifting towards biosimilars, with original product sales declining from approximately 30.4 trillion KRW (about 20.3 billion USD) to 17.2 trillion KRW (about 11.5 billion USD) over the past year. Celltrion aims to capitalize on this market change to secure a leading global position.
A Celltrion spokesperson stated that following the expansion of prescriptions in the U.S., this approval allows us to offer differentiated administration options in Canada. It will leverage our proven product competitiveness and full lineup synergy to lead the global ustekinumab market across North America.