On December 7th, Health Canada released a revised draft of Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars) for stakeholder consultation. The obective of the Guidance, entitled “Information and Submission Requirements for Subsequent Entry Biologics (SEB Guidance)“, is to provide sponsors with guidance to satisfy the information and regulatory requirements under the Canadian Food and Drugs Act and Regulations for the authorization of SEBs in Canada.

The Guidance Document and information on submitting feedback may be found here. Comments will be accepted until February 15th.