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Biosimilars in Canada and Europe. AIPLA Biotechnology Committee Webinar Noel Courage. September 25, 2012. Europe. Europe has been a leader in biosimilar guidance and approvals. Guidelines for insulin, G-CSF, EPO, somatropin , LMW heparins, interferon alpha
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Biosimilars in Canada and Europe AIPLA Biotechnology Committee Webinar Noel Courage September 25, 2012
Europe Europe has been a leader in biosimilar guidance and approvals. Guidelines for insulin, G-CSF, EPO, somatropin, LMW heparins, interferon alpha December 2012: monoclonal Ab guidance takes effect
MonclonalAb guidance clinical and non-clinical issues -demonstrate biosimilarity to reference antibody -if several indications, not required to investigate pharmacokinetic profile in all. More PK studies if distinct therapeutic areas. 2. Immunogenicity -eg: analyze glycosylation patterns, mechanism of action, clinical factors -risk management plan to prevent, measure, and medically treat adverse immune response
Canada Did not need to implement specific legislation to create biosimilar pathway Using existing regulatory structure
Canada – simple and transparent approach New biologics and biosimilars both approved via NDS, egsomatropin No product-specific guidance. Health Canada recommends consulting EP guidance HC committed as of September 2012 to publish reasons for biosimilar approvals
Cdn. News: G-CSF biosimilar Teva filed NDS in Canada Amgen CA patent 1,341,537 expires 2024 (17 yrs from issuance; DNA, protein, process of production) Amgen trying to block Teva’s marketing authorization Teva alleges patent invalid
Linkage Regulations • Canada: • Linkage regs - Health Canada Patent Register • EP: • No linkage regs
Naming EP: filgrastim US: tbo-filgrastim Canada: likely to follow EP’s lead, as with somatropin
Regulatory Threshold • Canada and EP stress importance of comparative clinical trials to demonstrate biosimilarity For more info see: N. Courage & A. Parsons. The Comparability Conundrum: Biosimilars in the United States, Europe and Canada, (2011) 66 Food and Drug Law Journal. • Will the US be any different in data requirements?
Exclusivities and Patents US leads EP and Canada on regulatory exclusivities Patent term extension possible in US, EP (SPC), not CA
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