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Biosimilars in Canada and Europe

Biosimilars in Canada and Europe

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Biosimilars in Canada and Europe

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  1. Biosimilars in Canada and Europe AIPLA Biotechnology Committee Webinar Noel Courage September 25, 2012

  2. 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

  3. 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

  4. Canada Did not need to implement specific legislation to create biosimilar pathway Using existing regulatory structure

  5. 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

  6. 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

  7. Linkage Regulations • Canada: • Linkage regs - Health Canada Patent Register • EP: • No linkage regs

  8. Naming EP: filgrastim US: tbo-filgrastim Canada: likely to follow EP’s lead, as with somatropin

  9. 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?

  10. Exclusivities and Patents US leads EP and Canada on regulatory exclusivities Patent term extension possible in US, EP (SPC), not CA

  11. Thank You! Sponsors: