A reference biologic is the original branded product approved by
Health Canada. When the patent for a reference biologic expires, manufacturers can make highly similar copies of the reference biologic, known as biosimilars. In Canada, biosimilars were previously called subsequent entry biologics (SEBs).
Biosimilars are not identical to their reference biologic drugs. However, based on Health Canada’s guidelines and approval standards for the pharmacokinetics, pharmacodynamics, safety and clinical efficacy of biologics, the two are highly similar. There are no clinically meaningful differences between biosimilars and their reference biologics.