Canadian Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)
Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada’s mandates and objectives should be implemented in a manner that is fair, consistent and effective.
Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada, recognizes that with the expiration of patents for biologic drugs, manufacturers may be interested in pursuing subsequent entry versions of these biologic drugs. The objective of this document is to provide guidance to sponsors to enable them to satisfy the information and regulatory requirements under the Food and Drugs Act and Regulations for the authorization of subsequent entry biologics (SEBs) in Canada.
This letter is a outlines Health Canada’s response to inquiries regarding SEBs and interchangeability and substitutability.