Health Canada Releases Revised Guidance on Subsequent Entry Biologics

Health Canada has released a revised version of the "Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)" (Revised Guidance), which updates the original version of the guidance document previously released in January, 2008 (Original Guidance) (for commentary on the Original Guidance, see "Health Canada Releases Draft Guidance on Subsequent Entry Biologics" E-TIPS®, Vol 6, No 20, April 9, 2008). The Revised Guidance is intended to reflect stakeholder comments received during consultations. The Revised Guidance contains information regarding the choice of reference biologic, requirements for Clinical Trial Applications, requirements for New Drug Submissions and for post-marketing. Two areas in which the Revised Guidance significantly expands on the information contained in the Original Guidance are the grant of clinical indications and the use of foreign reference products. Like the Original Guidance, the Revised Guidance states that SEBs are not "generic biologics" and that the authorization of an SEB is not a declaration of pharmaceutical and/or therapeutic equivalence to the reference biologic. Although the Original Guidance foresaw a mechanism in which substitutability may be granted "separate from and/or subsequent to market authorization of a SEB", any suggestion of such a mechanism has been removed from the Revised Guidance. Although the Original Guidance suggested that the Food and Drug Regulations (FDR) would be amended to provide an approval pathway for SEBs, it now appears that SEB regulation will take place entirely through guidance documents. The Revised Guidance states that the existing regulatory framework for biologics, pharmaceutical and generic drugs, is the basis for SEB regulation and that the laws outlined in the Patented Medicines (Notice of Compliance) Regulations (PM (NOC) Regulations) and FDR (Data Protection) provisions are applicable to SEBs. To account for the applicability of these laws to SEBs, Health Canada released in tandem with the Revised Guidance, draft amendments to the "[PM(NOC) Regulations]" and "Data Protection under C.08.004.1 of the [FDR]" guidance documents. Comments on the guidance documents will be accepted until May 26, 2009. For the Revised Guidance, see: http://tinyurl.com/dmwyz7 For the proposed additions to the "Guidance Document: [PM(NOC) Regulations]", see: http://tinyurl.com/dey3s2 For the proposed revisions to the "Guidance Document: Data Protection under C.08.004.1 of the [FDR]", see: http://tinyurl.com/dljydq Summary by: Michael Migus