December 23, 2016
Health Canada has released its revised guidelines for submission requirements for biosimilar biologic drugs. The “Guidance Document Information and Submission Requirements for Biosimilar Biologic Drugs” was posted online December 2nd 2016.
There are several revisions from the 2010 guidelines, one of which is the terminology of the class of drug. Health Canada will be replacing the term subsequent entry biologic with “biosimilar biologic drug” or “biosimilar” to bring consistency with the US and Europe’s terminology.
The updated guidelines specify that the sponsor must identify the biologic drug authorized in Canada to which it is subsequent and to which it is making a comparison. Where there is a non-Canadian reference biologic drug, the sponsor must address the relationship between the non-Canadian reference biologic drug and the Canadian version to support the suitability of the chosen reference biologic. (2.1.3 Reference biologic drug)
Health Canada will authorize specific indications based on the similarity between the biosimilar and the reference biologic based on comparative structural, functional, non-clinical and clinical studies. “Where similarity has been established, indications may be granted even if clinical studies are not conducted in each indication”. As well, a scientific rationale to justify the authorization in each indication should be provided. (2.3.4 Authorization of indications)
Health Canada has also stated that market authorization of a biosimilar does NOT infer equivalence to the reference biologic and “the designation of a drug as interchangeable is under the purview of the provinces and territories”.
Health Canada did not make any determination in this guidance document regarding its practice for naming biosimilars and for now, biosimilars will continue to be identified by brand name, non-proprietary name and Drug Identification Number (DIN).
For a comprehensive list of additional revisions and further details to the guidelines, please refer to “Notice to Stakeholders - Release of the Revised Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs”
For the complete Guidance Document regarding Information and Submission Requirements for Biosimilar Biologic Drugs please click here
For more information, please contact, Marla Weingarten, Consultant, The Pangaea Group