Background: Patents on several biologics will expire in Canada in the coming years. As they expire, applications to market subsequent entry biologics (SEBs) may be filed in Canada.
Objective: To provide an understanding of the regulatory pathway and types of trials used for SEB authorization in Canada.
Methods: Health Canada's draft guidance on SEBs was reviewed in regards to key issues and challenges in the development and authorization of SEBs.
Results: Health Canada states that SEBs are not "generic biologics" and their authorization is not a declaration of pharmaceutical or therapeutic equivalence to the originator. The agency recommends that physicians make well-informed decisions regarding therapeutic interchange.
Conclusions: Decisions on how to determine the place of SEBs in clinical practice for biologic-naive patients and those already receiving biologics should be made on a case-by-case basis, considering the patient's needs, the characteristics of the biologic required, and the clinical development programs of the applicable SEB.
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| http://dx.doi.org/10.2310/7750.2013.13006 | DOI Listing |
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