Subsequent entry biologics sebs canada aipla biotechnology committee webinar march 29 2012
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Subsequent Entry Biologics (SEBs) – Canada AIPLA Biotechnology Committee Webinar March 29, 2012. Daphne C. Lainson dclainson@smart-biggar.ca. Health Canada. Health Canada approval, Food and Drugs Act : Human and veterinary pharmaceuticals Human biologics Canadian Food Inspection Agency

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Subsequent entry biologics sebs canada aipla biotechnology committee webinar march 29 2012

Subsequent Entry Biologics (SEBs) – CanadaAIPLA Biotechnology Committee WebinarMarch 29, 2012

Daphne C. Lainsondclainson@smart-biggar.ca


Health canada
Health Canada

  • Health Canada approval, Food and Drugs Act:

    • Human and veterinary pharmaceuticals

    • Human biologics

  • Canadian Food Inspection Agency

    • Veterinary biologics


Innovator regulatory pathway
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)


Subsequent e ntry pathway
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


Guidance document
Guidance Document

  • Released March 5, 2010: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/notice-avis_seb-pbu_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


Reference biologic
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


Guidance other highlights
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


Hatch waxman canadian style
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


Noc regulations notable distinctions with us
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)


Trigger
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?


Data protection
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


Data term
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


Seb innovative drug
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


Trigger1
Trigger

  • Subsequent entry sponsor must make direct or indirect comparison to innovative drug

  • Questions:

    • Hybrid submissions


Status of sebs
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


Patented medicine prices review board jurisdiction
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