SEBs in Canada

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5 Δεκ 2012 (πριν από 4 χρόνια και 6 μήνες)

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Subsequent Entry Biologics
(SEBs)


Canada

Presentation to AIPLA Biotechnology
Committee

January 25, 2012


Daphne C. Lainson

dclainson@smart
-
biggar.ca

2

Health Canada


Health Canada approval,
Food and Drugs Act
:


Human and veterinary pharmaceuticals


Human biologics


Canadian Food Inspection Agency


Veterinary biologics

3

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)

4

Subsequent
E
ntry 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

5

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





6

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


F
oreign reference biologic permitted where
marketed
by same innovator or corporate entity in Canada in
same dosage form as approved Canadian biologic



7

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


8


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


9

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)


10

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?



11

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

12

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


13

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

14

Trigger


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


Questions:


Hybrid submissions


15

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

16

PMPRB 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

17

Hot Topics


Monoclonal antibodies


working examples
(preparation and characterization) may be required


Utility: demonstration vs. sound prediction


Teva Canada Limited v. Pfizer Canada Inc. (VIAGRA),
SCC hearing in February 2012


CETA


Comprehensive Economic and Trade
Agreement between Canada and Europe



Thank You