BIOSIMILARS PORTAL
Main
Gowlings Expertise
Gowlings Professionals
Policy Positions
Presentations & Articles
Life Sciences & Law Current Issues 2011/12
SEBs: Are We Ready?
LINKS
CANADA
Health Canada
Pricing / Reimbursement
Legislation, Regulations & Guidances
OMNITROPE
UNITED STATES
Food & Drug Administration
Legislation, Regulations & Guidances
EUROPE
Legislation, Regulations & Guidances
INTERNATIONAL/OTHER COUNTRIES
Legislation, Regulations and Guidances
European Medicines Agency
Questions and Answers on biosimilar medicines (similar biological medicinal products)
- October 22, 2008
Concept Paper on the Development of a Committee for Proprietary Medicinal Products (CPMP) Guideline on Comparability of Biotechnology-Derived Products
- June 24, 1998
Consultation re: Concept Paper EMEA Biosimilar Monoclonal Antibodies (released October 2009 with comments due January 31, 2010)
Montréal
Ottawa
Kanata
Toronto
Hamilton
Waterloo Region
Calgary
Vancouver
Moscow
London
Privacy
|
Terms of Use
© 2010 Gowling Lafleur Henderson LLP. All rights reserved.