Background: Patents on several biologies will expire in Canada in the coming years. As they expire, applications to market subsequent entry biologies (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 Methods: Health Canada's draft guidance on SEBs was reviewed in regards to key issues and challenges in the development and authorization of SEBs.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 biologies” 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 biologies 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.
Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs