Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs

Summary

In Canada and worldwide there is a need for updated independent real-world comparative effectiveness and safety data related to biologic drugs including biosimilar drugs. Biosimilar drugs hold potential to improve access to needed therapies at reduced cost enabling savings to be reallocated to other needs. However updated real-world evidence on comparative effectiveness and safety of biosimilar drugs is lacking. Investigators aim to demonstrate feasibility of creating network of clinical cohorts and other resources to provide real-world information on use of biosimilar drugs in Canada.

The core revolves around clinical datasets but investigators will complement with other data sources. Investigators will review data from National Prescription Drug Utilization Information System database that contains prescription claims-level data collected from publicly financed drug benefit programs in different provinces to conduct an environmental scan of the use of biosimilars and respective legacy drugs and other anti-Tumor Necrosis Factor agents covered by provincial drug plans from 2014-2017. Initial analysis will help to confirm that use of biosimilars is lower than corresponding legacy drugs.

Biologic drugs are relatively new and expensive drugs; biosimilar medicines are similar to original biologic drugs but cost less. If patients receive biosimilar drugs rather than originator biologics healthcare systems may be able to save money. Those savings can be used for other health care needs to benefit more Canadians. However investigators do not have detailed information on safety and effectiveness of these biosimilar drugs. The aim of study is to compare safety and effectiveness of biosimilar drugs to originator biologic drugs. Investigators will study patients with inflammatory rheumatic diseases (RA and AS) and Inflammatory Bowel Disease (CD and UC) and across Canada on these drugs. Primary focus is on patients without history of biologic drug use but investigators will also study patients switching to biosimilar drug from an originator biologic drug. Investigators will measure how long patients stay on treatment, if patients require new treatment, if the patients' disease control improves and occurrence of side effects such as infection that could be related to these drugs.

Conditions

• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Ulcerative Colitis
• Crohn's Disease

Interventions

DRUG

Biosimilar

Biologic-naïve patients starting any biosimilar; patients switching to biosimilar from an alternative biologic therapy; or patients switching to a biosimilar after successfully completing and exiting a previous course of therapy with the equivalent originator drug.

DRUG

Originator (legacy) drug

Biologic-naïve patients starting any originator (legacy) drug; patients switching to an originator drug from an alternative biologic therapy; or patients starting a new cycle with the originator drug.

Sponsors & Collaborators

• Université de Sherbrooke

  collaborator OTHER

• Institut de rhumatologie de Montréal

  collaborator UNKNOWN

• Hospital for Special Surgery, New York

  collaborator OTHER

• University of Manitoba

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• Alberta Health services

  collaborator OTHER

• McMaster University

  collaborator OTHER

• The Arthritis Program Research Group

  collaborator UNKNOWN

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-26

Primary Completion

2021-03-30

Completion

2022-12-31

FDA Drug

Yes

Countries

• Canada

Study Locations