Dermatology 2013

ISSN: 1203-4754 (Print)

1203-4754 (Linking)

Accession Number: 24067855

Keywords: *Biological Products

Canada

*Dermatology

Drug Approval/*organization & administration

*Drugs, Generic

Humans

*Rheumatology

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 METHODS: Health Canada’s draft guidance on SEBs was reviewed in regards to key issues and challenges in the development and authorization of SEBs.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

Bourcier, Marc

Ho, Vincent

Burke, Karen

Haraoui, Boulos

eng

Canada

2013/09/27 06:00

J Cutan Med Surg. 2013 Sep-Oct;17(5):340-6.

URL: http://www.ncbi.nlm.nih.gov/pubmed/24067855

 

 

Reference Type:  Journal Article

Record Number: 4544Author: Park, K. K. and Koo, J.

Year: 2013

Title: Use of psychotropic drugs in dermatology: unique perspectives of a dermatologist and a psychiatrist

Journal: Clin Dermatol

Volume: 31

Issue: 1

Pages: 92-100

Date: Jan-Feb

Short Title: Use of psychotropic drugs in dermatology: unique perspectives of a dermatologist and a psychiatrist

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