Health Canada approves Celltrion’s Steqeyma®, a biosimilar to Stelara® (ustekinumab) for the treatment of multiple chronic inflammatory conditions

• Steqeyma^® (CT-P43), is now approved in Canada for adult patients with plaque psoriasis as well as adults with active psoriatic arthritis and Crohn’s disease¹
• The approval of Steqeyma reinforces Celltrion’s commitment to high-quality, affordable biologic therapies for people living with chronic diseases
• Steqeyma adds to Celltrion Healthcare Canada's biosimilar portfolio, which includes Yuflyma^® and Remsima SC^®, rounding out a comprehensive offering in the immunology space

TORONTO--(BUSINESS WIRE)--Celltrion Healthcare Canada Limited today announced that Health Canada has approved Steqeyma^® (ustekinumab injection) and Steqeyma^® I.V. (ustekinumab for injection, solution for intravenous infusion) for the treatment of moderately to severely active Crohn’s disease in adults, moderate to severe plaque psoriasis in adult patients, and active psoriatic arthritis.¹

“We are delighted about the addition of Steqeyma to our pipeline, further strengthening our presence in immunology,” said Jungyong Shin, Managing Director at Celltrion Healthcare Canada. “This approval of Steqeyma reflects our strong commitment to increasing patient access to affordable, high-quality biologic medicines.”

The approval was based on the totality of evidence, including the results from a Phase III study in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The efficacy results were comparable between the treatment groups up to Week 52 in patients with moderate-to-severe plaque psoriasis. Half of the patients originally receiving the reference product, Stelara, switched to Steqeyma at Week 16, demonstrated comparable efficacy and safety to those who remained on the reference product. Steqeyma was well-tolerated and comparable to the reference product ustekinumab with no notable safety issue.

“Plaque psoriasis and psoriatic arthritis are debilitating, inflammatory diseases that impact patients’ quality of life in various ways,” said Dr. Kim Alexander Papp, MD, PhD, Probity Medical Research, Waterloo and University of Toronto. “Approximately 1 million Canadians are affected with psoriasis. The introduction of this new therapeutic option offers renewed hope for individuals managing psoriasis and related chronic inflammatory conditions.”

Notes to Editors:

About Steqeyma^®, Steqeyma^® I.V.

Steqeyma^® and Steqeyma^® I.V., is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases. It is indicated for the treatment of active psoriatic arthritis (PsA) and Crohn’s disease (CD) in adults, and plaque psoriasis (PsO) in adult patients. Steqeyma is available in both subcutaneous and intravenous formulations. The subcutaneous injection is available in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial.

About Celltrion Healthcare Canada

Celltrion Healthcare Canada is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with Health Canada regulations, the U.S. FDA cGMP and the EU GMP guidelines. Celltrion endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.ca

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¹Steqeyma Product Monograph. Celltrion Inc. July 2024. Product information from Health Canada.

Steqeyma^® is a registered trademark of Celltrion, Inc. and is used under license.
Stelara^® is a registered trademark of Johnson & Johnson.