Celltrion said it has received New Drug Submission (NDS) approval from Health Canada for its biosimilar Steqeyma.

Steqeyma, a biosimilar referencing Janssen's Stelara (ingredient: ustekinumab), is set to treat various inflammatory diseases including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Stelara is one of the top-grossing biopharmaceuticals globally, with sales reaching $20.3 billion in 2023, according to IQVIA.

With this approval, Celltrion can now market Steqeyma in Canada for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease. 

Before Canada, the company received approval for Steqeyma from the Ministry of Food and Drug Safety in June of this year and a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in late June. 

With the approval in Canada, Celltrion not only expands its autoimmune disease treatment portfolio in the North American market but also strengthens its market presence. 

In addition to previously launched products such as Remsima, Remsima SC (marketed as Zymfentra in the U.S.), and Yuflyma, Celltrion is broadening its therapeutic areas to include interleukin (IL) inhibitors, significantly expanding its patient base.

"Canada is known for its proactive pro-biosimilar policies, encouraging the prescription of biosimilars,” a Celltrion official said. “Celltrion's influence in Canada will continue to grow with our diverse product portfolio.”

Also, as North America is the largest market for ustekinumab globally, the approval of Steqeyma in Canada is expected to be a crucial starting point for our North American market strategy, he added.