Big News: Celltrion’s Steqeyma Approved for Use In Canada

Celltrion Inc. of South Korea has secured new drug submission (NDS) approval from Health Canada for its biosimilar, Steqeyma, which targets the treatment of autoimmune diseases and is a counterpart to Stelara. With this recent approval, announced on Wednesday, Celltrion is now permitted to market Steqeyma in Canada for conditions such as plaque psoriasis, psoriatic arthritis, and Crohn's disease. Celltrion is setting its sights on the North American market, the largest pharmaceutical sector globally, beginning with Canada. The company aims to carve out a significant share in the global ustekinumab market, the active ingredient found in Stelara.

According to IQVIA, a pharmaceutical market research firm, the global ustekinumab market was valued at $20.4 billion last year. The Canadian market alone is estimated at $663 million, while the broader North American market, which includes the United States, is worth $16.4 billion, representing over 80% of the global total. Earlier this year, Celltrion received approval for Steqeyma in South Korea, followed by a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Upon receiving final European market authorization, the company anticipates a significant boost in its efforts to penetrate the global ustekinumab market. The company aims to not only enhance its portfolio of autoimmune disease treatments in North America but also solidify its market standing. Alongside its current lineup of tumor necrosis factor (TNF)-alpha inhibitors, including Remsima, Remsima SC, and Yuflyma, the addition of interleukin (IL) inhibitors will enable the company to reach a wider patient population.