A biologic drug demonstrated to be similar to a brand name drug already authorized for sale (known as the reference biologic drug). Biosimilars were previously known in Canada as subsequent entry biologics (SEBs). Biosimilars may enter the market after the expiry of reference biologic drug patents and data protections. Biosimilars are regulated as new drugs under the Food and Drugs Act and the Food and Drug Regulations. To obtain authorization as a biosimilar, the drug manufacturer must provide information to Health Canada to show that the biosimilar and the reference biologic drug are similar and that there are no clinically meaningful differences in terms of safety and efficacy between them. [From: