Celltrion said on the 20th that it obtained additional approval from Health Canada for the auto-injector (AI) formulation of the autoimmune disease treatment biosimilar "Steqeyma" (ingredient name ustekinumab).
With this approval, Celltrion secured two AI formulations in Canada: 45mg/0.5mL and 90mg/1.0mL. Beyond the existing formulation, the dosage and method of administration have been expanded.
Steqeyma now includes a self-injection formulation not available with the local reference biologic.
Steqeyma is listed in the formularies of some insurance plans among major pharmacy benefit managers (PBMs) in the United States. As of Jan., the U.S. ustekinumab market share was tallied at 8.6%.
The self-injection formulation allows patients to administer the drug themselves, and demand for it has been rising recently.
The company said it plans to continue responding to the North American market based on the formulations secured in Canada.