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- W49093681 abstract "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 Methods: Health Canada's draft guidance on SEBs was reviewed in regards to key issues and challenges in the development and authorization of SEBs.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." @default.
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- W49093681 date "2013-09-01" @default.
- W49093681 modified "2023-09-25" @default.
- W49093681 title "Preparing for Subsequent Entry Biologies in Dermatology and Rheumatology in Canada" @default.
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- W49093681 doi "https://doi.org/10.2310/7750.2013.13006" @default.
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