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 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.
UMass Memorial Medical Center, University of Massachusetts Medical School, Worcester, Massachusetts 01605, USA. jonathan.kay@umassmemorial.org
Jonathan
J
Kay
Brian G
BG
Feagan
Micheal S
MS
Guirguis
Edward C
EC
Keystone
Agnes V
AV
Klein
Anthony S
AS
Lubiniecki
Diane R
DR
Mould
Kwasi A
KA
Nyarko
Anthony A G
AA
Ridgway
Maureen E
ME
Trudeau
Jian
J
Wang
D001688:Biological Products; D002170:Canada; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry
D001688:Biological Products