Celltrion Obtains Approval for Pediatric Vial Formulation of 'Stekeyma' in North America

Pediatric Plaque Psoriasis Indication Approved in Canada
Expanding IL Inhibitor Portfolio to Strengthen Influence in the Autoimmune Disease Market

Celltrion announced on the 16th that it has obtained additional product approvals for its autoimmune disease treatment 'Stekeyma (STEQEYMA)', a biosimilar of 'Stelara(STELARA, active ingredient ustekinumab)', in the 45mg/0.5ml vial formulation from both the U.S. Food and Drug Administration (FDA) and Health Canada.

The newly approved 45mg vial of Stekeyma in North America is intended for use in pediatric patients. Unlike adults, pediatric patients require fine-tuned dosing based on body weight, so the low-dose vial formulation is prescribed for them.

With this latest approval for the 45mg vial, Celltrion now offers a total of four dosage forms of Stekeyma: the existing 45mg/0.5ml pre-filled syringe (PFS), 90mg/1ml PFS, 130mg/26ml vial, and the newly approved 45mg/0.5ml vial. This expanded lineup enables tailored dosing according to patient condition and prescription requirements, which is expected to not only strengthen Stekeyma's product competitiveness but also increase product preference among patients.

Since receiving regulatory approval in Canada in July and in the United States in December last year, Stekeyma has begun targeting the North American market, the world's largest pharmaceutical market, and is steadily establishing itself in the global ustekinumab market. Notably, Celltrion recently obtained additional approval in Canada for the pediatric plaque psoriasis indication, allowing Stekeyma to be marketed for all indications held by the original product in both the United States and Canada. In the U.S., Celltrion has secured coverage by signing contracts with two of the top five pharmacy benefit managers (PBMs), which together account for about 90% of the total insurance market, and is currently negotiating with other PBMs as well.

Celltrion plans to further strengthen its presence in the autoimmune disease market by expanding its share in the interleukin (IL) inhibitor segment, which includes Stekeyma, in addition to its existing tumor necrosis factor-alpha (TNF-α) inhibitor portfolio in North America, which includes Remsima, Zymfentra (the U.S. brand name for Remsima SC), and Yuflyma.

According to pharmaceutical market research firm IQVIA, the global ustekinumab market is estimated to be worth approximately $21.66515 billion (about KRW 30.3312 trillion) as of 2024. Of this, the U.S. market accounts for about $16.70381 billion (about KRW 23.3853 trillion), and the Canadian market is about $647.81 million (about KRW 906.9 billion), meaning that the combined North American market represents about 80% of the total.

A Celltrion representative stated, "With the approval of the 45mg vial of Stekeyma, we can now provide treatment opportunities for pediatric autoimmune disease patients in North America," and added, "With the expanded range of dosage forms, we can offer customized prescriptions for various cases, and we will actively leverage Stekeyma's product competitiveness in our marketing efforts to maximize our market share in North America."