November 8, 2014
ISSN: 1203-4754 (Print)
Accession Number: 24067855
Keywords: *Biological Products
Drug Approval/*organization & administration
Abstract: 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 METHODS: Health Canada’s draft guidance on SEBs was reviewed in regards to key issues and challenges in the development and authorization of SEBs.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.
Notes: Papp, Kim
J Cutan Med Surg. 2013 Sep-Oct;17(5):340-6.
Reference Type: Journal Article
Record Number: 4544Author: Park, K. K. and Koo, J.
Title: Use of psychotropic drugs in dermatology: unique perspectives of a dermatologist and a psychiatrist
Journal: Clin Dermatol
Short Title: Use of psychotropic drugs in dermatology: unique perspectives of a dermatologist and a psychiatrist