Biosimilars in the Era of Artificial Intelligence: Canada's Health Regulations and Their Role in the Approval Process

Biosimilars, highly similar alternatives to reference biologic drugs, are revolutionizing healthcare in Canada by offering cost effective solutions for treating chronic and complex diseases, such as cancer and autoimmune disorders. Governed by Health Canada under the Food and Drugs Act and its regulations, the biosimilar approval process is rigorous, emphasizing safety, efficacy, and quality through comprehensive comparative studies and standardized product monographs. This article provides an in depth exploration of Canada’s regulatory framework for biosimilars, drawing on key Health Canada guidance documentsand international perspectives.