Transcript Subsequent Entry Biologics (SEBs) – Canada*

Subsequent Entry Biologics
(SEBs) – Canada
AIPLA Biotechnology Committee
Webinar
March 29, 2012
Daphne C. Lainson
[email protected]
Health Canada
• Health Canada approval, Food and Drugs Act:
• Human and veterinary pharmaceuticals
• Human biologics
• Canadian Food Inspection Agency
• Veterinary biologics
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Innovator Regulatory Pathway
• Clinical trial application (CTA)
• New drug submission (NDS)
• Post-approval changes
• “Administrative” NDS - changes in name of manufacturer,
brand name
• Supplemental NDS (SNDS) - non-administrative changes
(e.g., changes in formulation, dosage form or use)
• Approval = Notice of Compliance (NOC) or NOC with
Conditions (NOC/c)
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Subsequent Entry Pathway
• NDS – Full data package
• Generic pharmaceutical submissions:
• Abbreviated NDS (ANDS)
• Supplemental ANDS (SANDS)
• Subsequent entry biologics (SEB) submissions:
• No abbreviated or SEB pathway in Food and Drugs
Act and Regulations
• Guidance only
• Q & A document
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Guidance Document
• Released March 5, 2010: http://www.hcsc.gc.ca/dhp-mps/brgtherap/applicdemande/guides/seb-pbu/notice-avis_sebpbu_2010-eng.php
• SEB approval: NDS with reduced data package
• SEB sponsor to show a “demonstrated similarity”
between the SEB and a suitable reference biologic
drug
• Well characterized products
• Example: well characterized proteins
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Reference Biologic
• Should not be another SEB
• Has significant safety and efficacy data
accumulated
• Should be same dosage form, strength and route of
administration as SEB
• Should be authorized for sale and marketed in
Canada
• Foreign reference biologic permitted where marketed
by same innovator or corporate entity in Canada in
same dosage form as approved Canadian biologic
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Guidance – Other Highlights
• Extrapolation of indications permitted
• Generics following ANDS pathway not permitted to
extrapolate
• Post-marketing changes to manufacturing process:
comparison is to SEB submission only
• Not required to compare to original reference
biologic – product drift (?)
• SEB approval not a demonstration of
pharmaceutical or therapeutic equivalence
• NOC Regulations and data protection provisions to
apply
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“Hatch-Waxman” Canadian Style
• Broad “Bolar” exemption
• It is not an infringement of a patent for any person to make,
construct, use or sell the patented invention solely for uses
reasonably related to the development and submission of
information required under any law of Canada, a province or a
country other than Canada that regulates the manufacture,
construction, use or sale of any product.
• Patented Medicines (Notice of Compliance) Regulations
• Not limited to pharmaceuticals, includes human biologics
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NOC Regulations – Notable
Distinctions with US
• Patent Register – similar to Orange Book, but:
• Linkage to any product approved by NOC, and
therefore includes human biologics, some devices
• Firm patent listing deadlines (late listing not possible)
• Listing not automatic: government eligibility review
(timing, subject-matter, relevance)
• Stay = up to 24 months
• NOC proceeding: not final determination of merits
• Patent infringement or validity trial may follow
• No patent term restoration (also, no PTE or SPCs)
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Trigger
• NOC Regulations engaged where subsequent
manufacturer makes a direct or indirect
comparison or reference to another drug marketed
in Canada with patents listed on Patent Register
• Questions:
• Hybrid submissions based on new and significant
clinical studies?
• Extrapolated indications: relevant patents not listed?
• Product drift: infringement of a valid patent claim
where previously no infringement?
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Data Protection
• First NOC issued after June 17, 2006 for an
“innovative drug”:
“a drug that contains a medicinal ingredient not
previously approved in a drug by the Minister and
that is not a variation of a previously approved
medicinal ingredient such as a salt, ester, enantiomer,
solvate or polymorph”
• Includes human biologics, and human or veterinary
pharmaceuticals
• Independent of patent status
• Can be lost if innovator is not marketing in Canada
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Data Term
• Pharmaceuticals and biologics: same data terms
• 6-year “no-file” period
• Data period: subsequent entry manufacturer cannot
file its submission for a period of 6 years after the
date of the first NOC for the innovative drug
• 8-year “no-grant” period
• Market exclusivity period: NOC cannot be granted for
a period of 8 years after the date of the first NOC for
the innovative drug
• 8½ years if pediatric extension applies
• No extensions or supplemental terms
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SEB – Innovative Drug?
• Guidance: SEB is not entitled to its own data term
• Definition of “innovative drug”: excludes same
medicinal ingredient and variations
• “variation” not fully defined
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Trigger
• Subsequent entry sponsor must make direct or
indirect comparison to innovative drug
• Questions:
• Hybrid submissions
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Status of SEBs
• Omnitrope approved 2009
• Health Canada is accepting SEB submissions, but
no further SEBs have yet been approved
• Government is considering a SEB pathway in its
comprehensive review and revision of the Food and
Drug Act and Food and Drug Regulations
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Patented Medicine Prices Review Board
Jurisdiction
• Controls price over which patented medicines are
sold in Canada
• Broad jurisdiction
• “merest slender thread” of a connection between
patented invention and medicine sold in Canada
• Applies to patentee and its licensees
• Authorized generics encompassed
• ratiopharm ordered to pay $65 million for sales of
ratio-salbutamol HFA to offset excessive price
revenue
• Same rationale would apply to authorized SEB
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Thank You