Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa, Canada, 14 May 2012

In May 2012, Health Canada and other participants held a National Summit on Subsequent Entry Biologics (SEBs). Health Canada released a guidance document in March 2010 describing policy positions and data requirements for approval of SEBs. While Health Canada and health agencies in other regulatory...

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Bibliographic Details
Published in:Biologicals 2012-11, Vol.40 (6), p.517-527
Main Authors: Kay, Jonathan, Feagan, Brian G., Guirguis, Micheal S., Keystone, Edward C., Klein, Agnes V., Lubiniecki, Anthony S., Mould, Diane R., Nyarko, Kwasi A., Ridgway, Anthony A.G., Trudeau, Maureen E., Wang, Jian
Format: Article
Language:English
Subjects:
Biological Products
Biosimilars
Canada
Drug Approval - legislation & jurisprudence
Drug Industry
drugs
education
Follow-on protein products
Interchangeability
issues and policy
manufacturing
physicians
Similar biological medicinal products
stakeholders
Subsequent entry biologics
Substitution
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Summary:In May 2012, Health Canada and other participants held a National Summit on Subsequent Entry Biologics (SEBs). Health Canada released a guidance document in March 2010 describing policy positions and data requirements for approval of SEBs. While Health Canada and health agencies in other regulatory jurisdictions are aligned on many scientific principles related to biosimilar drugs, Health Canada's specific requirements may not be widely understood by many Canadian stakeholders. The Summit provided an opportunity for education and dialog among physicians who prescribe biologics, provincial payers, and industry on the following topics: preclinical and clinical comparability studies; manufacturing and other product differences; extrapolation of indications; substitution and interchangeability of SEBs with reference biologic drugs in clinical practice; payers' current perspective; pharmacovigilance and naming. It is anticipated that the consensus reached at this meeting will further educate Canadian healthcare professionals, provincial payers, and insurers about the appropriate use of SEBs, and may be of general interest to others internationally.
ISSN:1045-1056
1095-8320
DOI:10.1016/j.biologicals.2012.09.010