Celltrion announced on June 16 that it has received additional regulatory approval from the U.S. Food and Drug Administration (FDA) and Health Canada for a new formulation of its biosimilar for autoimmune diseases, STEQEYMA (development code: CT-P43).
The newly approved formulation is a 45mg/0.5mL vial, primarily intended for treating pediatric patients. Unlike adults, pediatric treatment requires precise dosing adjustments based on body weight, making low-dose formulations essential. This approval brings the total number of available STEQEYMA formulations to four, including a 45mg/0.5mL prefilled syringe, 90mg/1mL PFS, 130mg/26mL vials, and now the pediatric-specific 45mg/0.5mL vial. This diversification significantly enhances prescription flexibility and product competitiveness.
STEQEYMA is a biosimilar of the original biologic 'Stelara' (Ustekinumab), used for treating autoimmune diseases. Celltrion first obtained approvals for this biosimilar in North America in 2023, marking its entry into the US and Canadian markets. Recently, in Canada, the approval was expanded to include indications for pediatric psoriasis, thereby securing full-label approval comparable to the original drug.
In the U.S., Celltrion has secured supply agreements with two major Pharmacy Benefit Managers (PBMs) that cover approximately 90% of prescription drug insurance market share, facilitating broader insurance coverage for STEQEYMA. Negotiations continue with other PBMs across the region.
Through STEQEYMA, Celltrion aims to broaden its portfolio beyond TNF-α inhibitors (such as Remsima, Zymfentra, and Yuflyma) into the Interleukin (IL) inhibitor market. This strategic move reinforces its position in the North American autoimmune treatment landscape.
Market research firm IQVIA reports that the global Ustekinumab market is projected to reach approximately $21.6 billion by 2024, with the U.S. accounting for around $16.7 billion and Canada approximately $650 million, representing about 80% of the North American market.
A Celltrion spokesperson stated, “The approval of the 45mg vial offers new treatment options for pediatric autoimmune patients in North America. With multiple formulations, we aim to enable personalized treatment and strengthen STEQEYMA’s market competitiveness, accelerating our share in the North American region.”
