Preparing for subsequent entry biologics in dermatology and rheumatology in Canada.
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Health Canada's draft guidance on SEBs was reviewed in regards to key issues and challenges in the development and authorization of SEBs.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.
Kim
K
Papp
Marc
M
Bourcier
Vincent
V
Ho
Karen
K
Burke
Boulos
B
Haraoui
D001688:Biological Products; D002170:Canada; D003880:Dermatology; D017277:Drug Approval / Q000458:organization & administration*; D016568:Drugs, Generic; D006801:Humans; D012219:Rheumatology
D001688:Biological Products; D016568:Drugs, Generic