https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/biosimilar-biologic-drugs.html
Biosimilar biologic drugs - Canada.ca
Overview of Health Canada drug submission process for biological, genetic and radiopharmaceutical products; links to related legislation and regulations, news...
biologic drugsbiosimilarcanada
https://cip2.gmu.edu/2015/08/06/will-increasing-the-term-of-data-exclusivity-for-biologic-drugs-in-the-tpp-reduce-access-to-medicines/
Will Increasing the Term of Data Exclusivity for Biologic Drugs in the TPP Reduce Access to...
https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/lot-release-program-schedule-d-drugs.html
Guidance on the Lot Release Program for Schedule D (biologic) drugs - Canada.ca
This document outlines the Lot Release Program and review and testing requirements for Schedule D biologic drugs.
on the lot