Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Health Canada has granted approval for Celltrion Healthcare Canada’s Steqeyma (ustekinumab injection) and Steqeyma IV (ustekinumab for injection, solution for intravenous infusion) for treating various chronic inflammatory conditions.
The treatment is authorised for use in adults with active Crohn's disease, plaque psoriasis, and active psoriatic arthritis. Credit: Eszter Miller from Pixabay.
Subscribe to our email newsletter
Classified as human IL-12 and -23 antagonists, Steqeyma and Steqeyma are I.V. biosimilar products to reference medicine Stelara.
The treatment is authorised for use in adults with moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis, and active psoriatic arthritis.
Canadian regulator adopted the decision based on comprehensive evidence, including data from a Phase III clinical trial.
This study’s primary goal was to measure the rate of improvement in the Psoriasis Area and Severity Index (PASI) for skin symptoms.
The findings up to Week 52 showed comparable efficacy between the biosimilar and the reference product, Stelara, in patients with moderate-to-severe plaque psoriasis.
At the 16-week mark of the study, half of the participants who were initially administered Stelara were transitioned to Steqeyma.
The outcomes confirmed that the efficacy and safety profiles of Steqeyma were equivalent to those who continued treatment with the original product.
Steqeyma’s tolerability was on par with ustekinumab, and no significant safety concerns were identified.
Patients have the option of two administration methods for Steqeyma: subcutaneous injection or intravenous infusion.
The subcutaneous form is available in two dosages: 45mg/0.5ml or 90mg/1ml solution in a single-use, prefilled syringe.
The intravenous option is offered as a 130mg/26ml (5mg/ml) solution in a single-dose vial.
Celltrion Healthcare Canada managing director Jungyong Shin said: “We are delighted about the addition of Steqeyma to our pipeline, further strengthening our presence in immunology.
“This approval of Steqeyma reflects our strong commitment to increasing patient access to affordable, high-quality biologic medicines.”
The latest development comes after the company’s Vegzelma (bevacizumab for injection) received Health Canada approval for treating five types of cancer.
A biosimilar of Avastin, Vegzelma is indicated for metastatic colorectal cancer; metastatic or recurrent non-small cell lung cancer (NSCLC); platinum-sensitive recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer; platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer; and malignant glioma (WHO Grade IV) – glioblastoma.
