WEZLANA™ (USTEKINUMAB), A BIOSIMILAR TO STELARA®, NOW AVAILABLE IN CANADA FOR CERTAIN CHRONIC INFLAMMATORY DISEASES
WEZLANA IS THE FIRST BIOSIMILAR TO STELARA TO BE AVAILABLE FOR CANADIAN PATIENTS IN ALL INDICATIONS
MISSISSAUGA, ON, March 4, 2024 /CNW/ - Amgen Canada today announced that WEZLANA (ustekinumab injection) and WEZLANA I.V. (ustekinumab for injection, solution for intravenous infusion), a biosimilar to STELARA, is now available in Canada. WEZLANA is the first biosimilar to STELARA to be approved by Health Canada for all indications. WEZLANA is indicated for adult and pediatric plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.[1]
"The availability of WEZLANA marks a significant milestone in expanding high quality therapeutic options for physicians and Canadian patients living with certain chronic inflammatory diseases," says Daniel Martinez, executive medical director, Amgen Canada. "The addition of WEZLANA to the Amgen biosimilars portfolio has the potential to increase access for patients and underscores our commitment to serve patients in Canada."
"Inflammatory diseases are complex and impact individual patients differently," says Dr. Marc Bradette, Clinical Professor of Medicine at Université Laval, Québec. "Biosimilars contribute to a more resilient and inclusive healthcare system, with optimal access to important treatments. WEZLANA offers a cost-effective option for patients with chronic inflammatory diseases, including inflammatory bowel disease."
Health Canada approval was based on a robust comprehensive data package, which found no clinically meaningful differences in efficacy, safety and immunogenicity between WEZLANA and STELARA.2 WEZLANA is available as a subcutaneous injection, 45 mg/0.5ml and 90 mg/ml and as an intravenous solution, 130 mg/26mL (5mg/mL).1
WEZLANA (ustekinumab injection) / WEZLANA I.V. (ustekinumab for injection, solution for intravenous infusion) is a biosimilar to STELARA (ustekinumab injection) / STELARA I.V. (ustekinumab for injection). A biosimilar is a biologic drug that was granted Health Canada approval based on a demonstration of similarity to a version previously authorized in Canada, known as the reference biologic drug. Ustekinumab is a fully human IgG1қ monoclonal antibody that binds with specificity to the shared p40 protein subunit of human cytokines interleukin IL-12 and IL-23. 1
Following a physical injury, or in certain conditions, inflammation is a normal, healthy response; however, inflammatory disorders that result in the immune system attacking the body's own cells or tissues may cause abnormal inflammation, which can result in chronic pain, redness, swelling, stiffness, and damage to normal tissues.3 In this case, the inflammation refers to a biological response to stimuli interpreted by the body to have a potentially harmful effect.3
Millions of Canadians suffer from various chronic inflammatory diseases,4 often considered "invisible" since it does not show telltale physical signs the way acute inflammation does.5 Chronic inflammatory diseases are a burden to humans because of life-long debilitating illness, increased mortality and high costs for therapy and care.6
The only way to detect chronic inflammation is to have an evaluation by a doctor including a physical exam and blood tests.5
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ontario's vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new uses for existing medicines in partnership with many of Canada's leading healthcare, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.
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REFERENCES
1 WEZLANA™ Product Monograph. Amgen Canada Inc. (December 2023). |
2 NCT04607980 study. Available at: https://clinicaltrials.gov/ct2/show/NCT04607980?term=ABP+654&draw=2&rank=2. |
3 https://www.hss.edu/condition-list_inflammatory-disorders.asp.. |
SOURCE Amgen Canada
Natasha Bond, Amgen Canada, 905-285-3007
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