Biosimilars have been a trending topic for the last decade. For the last 15 years, they have been authorized to use in the European Union. Ontario joined the initiative to expand the use of biosimilar medications, following British Columbia, Alberta, New Brunswick, Quebec, Northwest Territories, Nova Scotia, and Saskatchewan.
Biosimilar drugs have been available in Europe since 2005. The first biosimilar to receive approval in Canada was Sandoz’s Omnitrope. To date, Health Canada’s list of approved biosimilars can be found here.
Biosimilars are becoming increasingly popular in the healthcare industry. Since they are essentially similar copies of their reference biologics and require less research and effort, they are more cost-effective to produce. It is essential to understand how they are regulated and how they affect patients, healthcare providers, and the pharmaceutical industry.
Throughout Canada, biosimilars are regulated by Health Canada, which is the Federal department responsible for ensuring the safety and efficacy of drugs and other health products. Health Canada requires that biosimilars undergo rigorous testing and clinical trials to ensure their safety and efficacy before they can be approved for use.
In addition to federal regulation, the Ontario government has also implemented policies to promote the use of biosimilars. The province has implemented a Biosimilars Initiative, which encourages healthcare providers to use biosimilars as a first-line treatment option where appropriate. This initiative is designed to improve patient access to safe and effective medications while also reducing healthcare costs. You can find the updated list of biosimilar drugs in Canada here.
According to biosimilars in Neurology, biosimilars are highly similar to an FDA & CFIA-approved biologic, known as the reference biologic. They are produced using living organisms and are often used to treat chronic diseases such as Cancer, Rheumatoid Arthritis, and Crohn’s disease. Biosimilars are rigorously tested for safety and efficacy before being approved for use.
Biosimilar regulations have an impact on healthcare providers. By promoting the use of biosimilars, healthcare providers can reduce the overall cost of healthcare while still providing effective treatment for their patients. However, healthcare providers must also be aware of the differences between biosimilars and reference products. They must carefully consider the safety and efficacy of the biosimilar before switching a patient from a reference product to a biosimilar.
Keep an eye out for the next chapter of Biosimilar Drugs in Canada, as we continue our exploration into this topic.