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Original Biologics and Biosimilars – are they equally effective and safe?
Safety and effectiveness of biosimilar anti-TNF agents in British Columbia – exploiting a natural experiment from a change in health policy.
Diane Lacaille, MD, MHSc, FRCPC Scientific Director, Arthritis Research Canada Mary Pack Chair in Rheumatology Research Professor, Division of Rheumatology, Associate Head of Academic Affairs, Department of Medicine, University of British Columbia
Why do this research?
Biologic medications or ‘Biologics’, also known as anti-TNF agents, have provided major advances to the treatment of Rheumatoid Arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), due to their unparalleled efficacy. Ten thousand British Columbians use biologics for RA, PsA and AS. But their high cost is a major barrier to their use and contributes to inequalities of care.
They are the most expensive drugs in health care budgets and are responsible for $125 million spent in B.C. in 2019. As many biologics are coming to the end of their patent, pharmaceutical companies are making equivalent drugs, called biosimilars, for a lesser cost. These less expensive alternatives would provide cost savings in health care budgets, allowing the health care system to afford newly discovered biologics as they come to market.
Research in clinical trials shows the biologic and biosimilar drugs have similar effectiveness and safety profiles. We want to gain more evidence from real-life clinical care settings, over long periods of time and in large samples in British Columbia, in face of the implementation in 2019 of a health policy that mandates prescriptions to be switched to biosimilars.
What will be done?
In British Columbia (BC), health policies direct that biosimilars, if available, be substituted for all new biologic drug prescriptions and that ongoing users be switched to biosimilars, so now we can gather data from people using biosimilars to evaluate them compared to the original biologic agents.
We will observe all patients with RA, PsA and AS in British Columbia, using real-life data on clinical care from the Ministry of Health until December 2020. That data will allow us to evaluate whether biosimilar medications are as safe and effective as the original biologics and whether people are able to remain on them for as long.
Our study will provide information to the BC Ministry of Health, health care professionals, patients, and the general public, as BC rolls out the biosimilar policy for other rheumatology drugs. The information will also be helpful to other provinces as they consider adopting a similar policy.
How do people get involved?
This study uses data that already exists and does not require the recruitment of participants.
Who is on the research team?
J. Antonio Aviña-Zubieta, MD, MSc, PhD, FRCPC Senior Scientist, Arthritis Research Canada Associate Professor of Medicine, Division of Rheumatology, Department of Medicine, University of British Columbia BC Lupus Society Research Scholar, Walter and Marilyn Booth Research Scholar
John M. Esdaile, MD, MPH, FRCPC, FCAHS, MACR Scientific Director, Arthritis Research Canada Professor of Medicine, Division of Rheumatology, Department of Medicine, University of British Columbia
Hui Xie, MSc, PhD Milan and Maureen Ilich/Merck Chair in Statistics for Arthritis and Musculoskeletal Diseases Professor, Faculty of Health Sciences, Simon Fraser University
Collaborators and partners:
Tijana Fazlagic, PharmD, BSP, M.Sc. (Pharm), Executive Director, PharmaCare Benefits Branch, BC Ministry of Health, Pharmaceutical Services Division
Jason Gordon, Pharmacist, Special Authority, PharmaCare Benefits Branch, BC Ministry of Health, Pharmaceutical Services Division
Stephanie Ensworth, BSc (Pharm), MD, FRCPC, ABIM Rheumatology & Complex Rheumatic Diseases, Clinical Associate Professor of Medicine, Division of Rheumatology, Faculty of Medicine, University of British Columbia, chair of the Rheumatic & Autoimmune Disease Adjudication Advisory Committee (RADBAC) for Pharmacare
Cathy Flanagan, MD, FRCPC, member of the RADBAAC Special Authority Committee, Clinical Assistant Professor, Division of Rheumatology, University of British Columbia
Allison Kydd, MD, FRCPC, member of the RADBAAC Special Authority Committee Clinical Assistant Professor, Division of Rheumatology, University of British Columbia
Cheryl Koehn, President, Arthritis Consumer Experts
Canadian Initiative for Outcomes in Rheumatology Care (CIORA)