Celltrion announced on the 16th that it received product approval for the low-dose formulation of the autoimmune disease treatment "Steqeyma" (Steqeyma®; active ingredient ustekinumab) in the United States and Canada.
"Steqeyma" is a biosimilar of Janssen’s Stelara in the United States. It was approved by the U.S. Food and Drug Administration (FDA) in December of last year for all diseases treated by Stelara, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Both intravenous (IV) and subcutaneous (SC) formulations have been released, similar to Stelara.
The FDA and Health Canada approved the 45 mg/0.5 mL vial formulation of "Steqeyma." This formulation is intended for pediatric patients. In the case of pediatric patients, fine adjustments to the drug dosage are necessary in proportion to body weight, so it will be prescribed in a low-dose vial formulation.
With the recent approval of the 45 mg low-dose vial, Celltrion has secured a product line with a total of four dosage formulations, including the existing vials. This allows for customized dosing based on the patient's condition and prescription dosage.
"Steqeyma" began targeting North America's largest pharmaceutical market after receiving approval in Canada and the United States in July and December of last year, respectively. In particular, it recently obtained additional approval for pediatric plaque psoriasis in Canada, allowing it to be marketed for the full range of diseases covered by the original product in Canada, following the United States.
According to IQVIA, a pharmaceutical market research organization, the global market size for ustekinumab is estimated to be approximately $21.66515 billion (about 30 trillion won) in 2024. Of this, the U.S. market size is about $16.7381 billion (23.3853 trillion won), and the Canadian market size is approximately $647.81 million (906.9 billion won), making the total North American market account for about 80% of the overall market.
Celltrion has signed contracts with two of the top five prescription benefit management companies (PBMs), which account for about 90% of the total insurance market in the U.S., and negotiations with other PBMs are ongoing. A Celltrion official noted, "With the approval of the 45 mg vial of Steqeyma, we are now able to provide treatment opportunities to pediatric patients with autoimmune diseases in North America."