Understanding biosimilars

What is a biologic drug?

To understand what a biosimilar medicine is, it is important to first take a look at biologic drugs.

Biologics are a class of drugs used to treat many kinds of diseases and medical conditions. They are large and complex compounds that come from living organisms or their cells, and include drugs such as insulin, growth hormones and antibodies.

What are biosimilars?

A biosimilar is a drug that is similar, but not identical, to a biologic medicine that Health Canada has already approved for sale. The biologic drug that a biosimilar is modelled after is called its reference biologic drug. The two have no clinically meaningful differences when it comes to safety and efficacy, but they do have some minor differences in the inactive ingredients used in their manufacturing process.

Biosimilars are not generic medicines

While biosimilars are sometimes confused with generics, it is important to remember that biosimilars are NOT generics. Unlike generics, biosimilars are not identical to their reference biologic drugs. Generic drugs are chemical-based, small molecule drugs that are generally easy to copy. Biologics and biosimilars, on the other hand, are large, complex molecules made inside living cells and are harder to copy.