Biosimilars - What You Need to Know

Reference Biologics

Biologic drugs have changed the way we treat and prevent many diseases like cancer, arthritis, diabetes, inflammatory bowel disease, psoriasis and vasculitis.
Biologics are complex and much harder to make than traditional drugs made using chemicals.
Biologics are made from living cells (like animal cells, bacteria or yeast) and therefore always have very small differences between batches.

Biosimilar biologics are highly similar copies of reference biologics.
They work just as well and may have the same side effects as their reference biologic.
Every biosimilar approved in Canada is just as high quality, safe and effective as all biologic drugs.
Biosimilar drugs are not the same as generic drugs. A generic drug has the exact same active ingredients (the chemicals that make the drug work) as a brand name drug. For example, you can buy ibuprofen as Advil (brand name) or a store brand (generic).
To date, more than 55 biosimilars have been approved in Canada, and more are likely to become available.

Biosimilars have been available in Europe for over 15 years. Switching from reference to biosimilar biologics has become common clinical practice.
Many Canadian provinces have switching policies in place.
Studies with over 21,000 people have shown that switching from a reference to a biosimilar biologic is safe and effective because biosimilar drugs work the same way as their reference biologic.
If you were taking a reference biologic drug and are now taking a biosimilar drug, you should expect to have the same results and the same side effects.
Talk with your health care provider if you have questions about switching to a biosimilar.

Reference biologic drugs are initially protected by a patent.
While reference biologic drugs are patent protected, only one company can sell that biologic, which makes them very expensive.
As the patents for reference biologic drugs expire, other companies can request approval from Health Canada to sell biosimilars.
The money that is saved with the use of biosimilar drugs can be used to fund new therapies.

In Canada, the cost of biologics has tripled over the last decade, reaching $10 billion in 2020. This is about one-third of all the money spent on medications.
If more Canadians were to use biosimilars, experts estimate that Canada could save up to $1.8 billion each year.

Biosimilars are approved and monitored by Health Canada to the same standards as the reference biologic drug.
Health Canada and manufacturers are both responsible for monitoring biologics and biosimilars.
Manufacturers must report any serious side effects to Health Canada, inform them of any studies with new safety information, and request their approval for any changes made to the drug.
Companies that make biosimilars must give information to Health Canada comparing the biosimilar with the reference biologic drug.
For a drug to be called a biosimilar, the company that makes the biosimilar must prove to Health Canada that it is safe and works just as well as the reference biologic drug.

Your care will be the same whether you take a reference biologic drug or a biosimilar drug.
As with taking any medications, if you have any problems while taking biosimilars, speak to your healthcare team right away.