The Biosim•Exchange: Canada’s trusted source for timely information on biosimilar biologics

Biosimilars have been used in Europe since 2006 and have led to over 700 million patient days of clinical experience.[1] During that time, tens of thousands of European Union patients with autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, gastrointestinal and bowel diseases have been using biosimilars with no compromise to patient safety, effectiveness or quality of care.

More than 170 research studies exist looking at patients who have successfully policy transitioned from a TNF inhibitor originator biologic to its TNF inhibitor biosimilar biologic and show no health differences between patients.

Learn more about biosimilars transition research

To stay informed, go to these sources for the latest research in North America and Europe:

Canadian Rheumatology Association Position Statement on Biosimilars

https://rheum.ca/canadian-rheumatology-association-cra-position-statement-on-biosimilars/

Canadian Rheumatology Association Biosimilar FAQ

https://rheum.ca/canadian-rheumatology-association-cra-position-statement-on-biosimilars/

Ontario Rheumatology Association Biosimilar Position Statement

https://ontariorheum.ca/ora-biosimilar-position-statement-2

European Medicines Agency: Biosimilars in the EU

https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf

American College of Rheumatology

https://www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/875

PubMed (National Center for Biotechnology Information)

http://www.ncbi.nlm.nih.gov/pubmed/

Evidence and additional reading:

etanercept

infliximab

insulin glargine

rituximab


Post marketing surveillance research
Tracking the efficacy, safety and value to patients and the health care system of both originator biologics and their biosimilar biologics is important. Patients and their physicians rely on this "real-world data" when they are making treatment decisions.
What is real-world data?

There are many, varied definitions of “real-world data” (RWD). Essentially, RWD is a measurement of the efficacy of a medication after it receives approval by Health Canada, when prescribed and used in a practical, real-life settings that go beyond what is normally collected in pre-approval clinical trials and studies. RWD comes from various sources and includes patient data, data from clinicians, hospital data, data from payers and social data. Through its use alongside traditional data sources (such as clinical trials), RWD has the potential to provide new insights into medicines and their effects in the context of different larger patient populations.

In the context of biosimilars, tracking the efficacy, safety and value to patients and the health care system of both originators and their biosimilars is important. Patients and their physicians rely on this “real-world data” when they are discussing and making treatment decisions.

When you are having a conversation about biosimilars as a treatment option with your healthcare professional or payer, ask them about these important real-world data discussion points:

  • What has been your experience with prescribing biosimilars?
  • Are you satisfied they are a safe and effective treatment option for me? Why?
  • Does the biosimilar you are recommending to me have a patient support program?
  • Where can I find reliable, easy-to-read information on biosimilars?

What research topics interest you the most?

Research and development of biosimilar medications is happening around the world at a rapid pace. Based on current research, what topics interest you the most?