28/02/22
Kirkland, Quebec – February 28, 2022 – Pfizer is proud to announce that ABRILADA™ (adalimumab), a biosimilar to the reference biologic drug Humira1 (adalimumab), is now available in Canada for the treatment of certain patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease (in people aged 13 and older), ulcerative colitis, plaque psoriasis, uveitis (in adults and children) and hidradenitis suppurativa (in people aged 12 and older)2.
“We believe biosimilars like ABRILADA play a key role in creating a more sustainable health care system, representing an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions,” said Frédéric Lavoie, Canada Lead, Pfizer Inflammation and Immunology. “Our current portfolio of approved biosimilar products is one of the broadest in the industry and we are proud to offer additional treatment options for patients.”
The Health Canada approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of ABRILADA to the reference biologic drug Humira. This includes results from the REFLECTIONS B538-02 clinical comparative study, which evaluated the efficacy, safety and immunogenicity of ABRILADA.3
About biosimilars
A biosimilar is a biologic drug that is highly similar to a biologic drug that was previously authorized for sale in Canada, called the reference biologic drug. Health Canada uses the same rigorous standards for quality, efficacy and safety when authorizing a biosimilar as any other biologic drug.4 Since 2009, Health Canada has approved 45 biosimilars for use by Canadian patients to treat cancer, diabetes, arthritis and inflammatory bowel disease.5
Pfizer’s commitment to biosimilars
As part of its commitment to delivering the highest value of care to patients, Pfizer is applying its significant resources and proven ability to meet the world’s health care challenges to develop and deliver high-quality biosimilars. Pfizer has nearly a decade of experience bringing biosimilar biologics to patients around the world.
About Pfizer in Canada
Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified healthcare portfolio includes some of the world’s best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Twitteror YouTube.
For Further Information
Pfizer Canada Corporate Affairs
1-866-9-PFIZER (1 866 973-4937)
[1] Humira is a registered trademark of AbbVie.
[2] ABRILADA Product Monograph. Available at www.pfizer.ca. Accessed February 2022.
[3] Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL. A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira) in the treatment of active rheumatoid arthritis. Arthritis Res Ther. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y. Available at https://www.ncbi.nlm.nih.gov/pubmed/30111357?dopt=Abstract Accessed February 2022.
[4] Health Canada Biosimilar biologic drugs in Canada: Fact Sheet
https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html Accessed February 2022.