MISSISSAUGA, ON (May 4, 2021) – Amgen Canada today announced that AMGEVITA® (adalimumab, reference biologic drug: Humira®), is now available in Canada for the treatment of 11 chronic inflammatory conditions.
Treatment with AMGEVITA® should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric (13 to 17 years of age weighing ≥ 40 kg) Crohn’s disease, ulcerative colitis, adult and adolescent (12 to 17 years of age weighing ≥ 30 kg) hidradenitis suppurativa, psoriasis or adult and pediatric uveitis and who are familiar with the AMGEVITA® efficacy and safety profile.i
"We are pleased that AMGEVITA® is now available in Canada, offering patients and physicians a treatment option and flexibility of choice in therapies they may not otherwise have,” says Suna Avcil, executive medical director, Amgen Canada. “AMGEVITA is an important milestone for Amgen’s biosimilar portfolio, expanding the number of treatment options available for Canadians living with chronic inflammatory diseases.”
AMGEVITA® is available as a prefilled syringe and a prefilled pen (SureClick® autoinjector) with a broad range of pack sizes to support dosing according to the approved dosage recommendations in each indication. Additionally, AMGEVITA® is provided in a citrate-free formulation.
“In my practice, I recognize the positive impact that access to additional therapeutic options can have on my patients and their quality of life,” said Dr. Kim Papp, Dermatologist, President and Director of Research at Probity Medical Research Inc. “The availability of AMGEVITA® offers specialists another important tool with which we can care for our patients living with chronic inflammatory disease.”
Biosimilars like AMGEVITA® are highly similar to, though often less expensive than, the original biologic therapies. In this way biosimilars, help increase the therapeutic options available to physicians and their patients and can help reduce the burden on Canada’s healthcare system.
AMGEVITA® is also now reimbursed on the public drug plans in British Columbia, Alberta, Ontario, Quebec, New Brunswick and Newfoundland for all available indications of the reference product.
AMGEVITA is a biosimilar to Humira® (adalimumab), a fully human immunoglobulin G1 monoclonal antibody that binds and neutralizes human tumor necrosis factor alpha (TNFα), a cytokine which mediates the inflammatory response. The amino acid sequence of AMGEVITA® is identical to that of the reference product.
About the AMGEVITA® Clinical Data
AMGEVITA® was approved based on a robust data package supporting biosimilarity to the reference product, Humira® brand adalimumab, based on analytical, nonclinical, pharmacokinetic and clinical data, including results from two confirmatory clinical studies conducted in moderate-to-severe psoriasis (PsO) and moderate-to-severe rheumatoid arthritis (RA) patients. The comparative clinical studies each met their primary endpoint showing no clinically meaningful differences from Humira® brand adalimumab. Safety and immunogenicity of AMGEVITA® were also comparable to Humira® brand adalimumab, and the data included a double-blind randomized switch from Humira® brand adalimumab to AMGEVITA®. AMGEVITA® was also evaluated in a long-term study in moderate-to-severe RA patients, which found that efficacy was maintained with no new safety findings.
About Chronic Inflammatory Diseases
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.iii In this case, the inflammation refers to a biological response to stimuli interpreted by the body to have a potentially harmful effect.iv
Millions of Canadians suffer from various chronic inflammatory diseases,v often considered “invisible” since it does not show telltale physical signs the way acute inflammation does.vi Chronic inflammatory diseases are a burden to humans because of life-long debilitating illness, increased mortality and high costs for therapy and care.vii
The only way to detect chronic inflammation is to have an evaluation by a doctor including a physical exam and blood tests.viii
About Amgen Canada
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.’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 health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.
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*Humira (adalimumab) is a registered trademark of AbbVieBiotechnology Inc.
i AMGEVITA PRODUCT MONOGRAPH, Patient Medication Information, November 4, 2020.
ii AMGEVITA PRODUCT MONOGRAPH, Patient Medication Information, November 4, 2020.