What does Health Canada mean when it refers to a reference biologic drug?
A reference biologic drug is a drug already approved on the basis of a complete quality, non-clinical and clinical data package. A reference biologic drug is chosen by the manufacturer of the Subsequent Entry Biologic to demonstrate, in part, similarity between the Subsequent Entry Biologic and the drug authorized for sale in Canada. 16. How does a reference biologic drug contribute to the approval of a Subsequent Entry Biologic product? The reference drug is utilized in the comparability studies required to support the licensing application and provides the basis for the sponsor to select the dose, route of administration, and design of additional clinical trials with the Subsequent Entry Biologic. 17. Will Health Canada make it mandatory that reference biologic drugs have to be approved and marketed in Canada? No, Health Canada will not make it mandatory that reference biologic drugs have to be approved and marketed in Canada. There are alternative means of obtaining credible and val
