Canadian Expert Patients in Health Technology Conference Nov 7 – 8, 2016: Day 2 Appropriate Place in Therapy Allan Miranda (Janssen), John Snowden (Amgen), Dawn Richards (Canadian Arthritis Patient Alliance), Seema Nagpal (Canadian Diabetes Association),

1. Allan F. Miranda Ph.D. MBA
Reimbursement Lead Immunology and Primary Care
Government Affairs and Market Access
November 8th, 2016
Appropriate Use of SEBs– What’s Next?
Jennifer Jacobs, Stowaway
Jennifer is a New York based artist
living with Type 1 diabetes.

2. Objectives
§ Key SEB policy issues
§ Impact on patient and physician choice
§ Future Look
2

3. J&J’s Position on SEBs
§ Johnson & Johnson fully supports a regulatory
framework for the approval of SEBs
§ Standards and policies must be based on an
understanding of the complexities of biologics
§ Patient safety is the key issue
§ SEBs are not generics
§ New policies designed for SEBs must maintain an
environment that encourages innovation
§ Our aim is education

4. Health Canada Position
§ SEBs are not “generic” biologics
§ SEB authorization is not a declaration of pharmaceutical or
therapeutic equivalence
§ Health Canada does not support interchangeability / automatic
substitution for SEBs
Health Products and Food Branch, Health Canada. Guidance for sponsors: information and
submission requirements for subsequent entry biologics (SEBs) http://www.hc-sc.gc.ca/dhp-mps/
brgtherap/applic-demande/guides/seb-pbu/seb-pbu_2010-eng.php
§ The relevance of specialized clinical studies that can be
used to support therapeutic interchangeability (which
are not usually done) will diminish over time as SEB and
reference biologic drug manufacturers make their own
independent manufacturing changes, differences could
be introduced that affect drug products
Biologics and Genetic Therapies Directorate: Letter to Provincial/Territorial Drug Plan
Directors. Re: Interchangeability/Substitutability of SEBs July 29, 2010 10-116885-569

5. SEB Substitution – International Summary
Country
Effec-ve
Date
(if
law
enacted)
New
vs
Exis-ng
Pa-ents
Can
Physician
Prevent
Subs-tu-on?
(Y/N)
Pa-ent
Consent
Required
(Y/N)
France1
Dec
2013
New
Y
N
Finland2
Recommenda2on
only
(May
22,
2015)
New
and
exis2ng
Y
N
Netherlands3
Recommenda2on
only
(April
27,
2015)
New
Y
N
United
Kingdom4
Individual
hospital/trusts
implemen2ng
switching
protocols
New
and
exis2ng
NA
Y
Australia5,6
June
23,
2015
New
and
exis2ng
Y
Y
USA*7
Varies
by
State
(following
FDA
designa2on)
New
and
exis2ng
Y
Y/N†
Note:
countries
included
above
are
those
for
which
detailed
SEB
subs2tu2on
informa2on
is
available
*
Legisla2on
enacted
on
individual
State
basis
†
The
following
states
require
pa2ent
consent
for
biosimilar
subs2tu2on
to
occur:
GA,
ND,
UT,
VA,
WA

6. Remaining on Stable Therapy: Patient Quotes
6
“Achieving
remission/stability
through
medica2on
provides
me
with
confidence.
The
idea
of
having
to
switch
medica-ons
for
non-­‐medical
reasons
makes
me
quite
nervous
and
could
seriously
compromise
that
confidence
that
has
taken
so
long
to
achieve!”
C.H.
(Canadian
IBD
pa-ent)
“I
have
had
an
18
year
history
to
finding
treatment
stability.
I
have
tried
countless
topicals,
orals,
lights,
tars,
diets
and
"cures"
combined
with
nine
clinical
trials,
four
of
which
were
biologics
of
which
three
failed
and
only
the
last
one
truly
stable
and
effec-ve.
Having
to
switch
would
put
me
back
into
misery,
pain
and
hopelessness.”
A.G.
(Canadian
psoriasis
pa-ent)
"It
seemed
like
forever
trying
to
find
the
treatment
that
would
gain
control
of
the
beast
that
was
ravaging
my
son.
Aaer
two
months
of
Remicade
treatment,
the
glimmer
of
the
boy
we
once
knew
slowly
came
back
to
us.
Stabilizing
my
son’s
Crohn’s
meant
more
than
controlling
inflamma2on,
it
gave
him
his
life
back
and
restored
the
family
life
we
desperately
missed.
The
thought
of
my
son
having
to
switch
from
a
treatment
he
has
thrived
on
for
almost
3/4
of
his
life,
is
unfathomable
to
me.
I
believe
the
impact
switching
would
have
on
my
son
could
be
detrimental,
and
forcing
him
to
switch
would
be
robbing
him
of
his
right
to
have
a
healthy
and
happy
life,
a
life
he
deserves.”
K.L.
(parent,
Canadian
CD
pa-ent)

7. What’s Next: SEBs in the Future
7
1.
SEB
in
IBD…
oncology
2.
Mul2ple
SEBs
for
each
innovator
3.Unprecedented
policy
change
4.
Impact
to
industry
5.
Erosion
of
physician
&
pa2ent
choice
6.
Erosion
of
value
of
innova2on
7.
Impact
on
pa2ent
experience
8.
Addi2onal
data
or
more
ques2ons?
9.
Language
causing
more
confusion?

8. Final Thoughts…
§ SEB products should increase patient and
physician choice not restrict or remove choice
§ Patients doing well on any treatment shouldn’t
be forced to switch
§ Value framework that appropriately balances
supporting clinical data, cost, innovation and
patient-based factors

9. Biosimilars: Appropriate Place in
Therapy
Canadian Experts in Health Technology Conference
November 7-8, 2016
John Snowden
Director, Biosimilars, Amgen Canada Inc.
© 2016 Amgen Inc. All rights reserved.

10. Biosimilars
Amgen’s Position on Biosimilars
• Amgen believes that biosimilars have a role to play in the health care
system
• Biosimilars -- unlike generic drugs -- are not identical to the originator
products they attempt to copy
• Amgen’s guiding principles:
Ensuring quality
manufacturing
Ensuring patient
safety
Following sound
science
© 2016 Amgen Inc. All rights reserved.
• Amgen believes in an open and competitive market that includes both
the biosimilars and innovators, and supports physician and patient
choice

11. Source: Letter to Provincial and Territory Drug Plan Directors from Director General BGTD Dr. Elwyn Griffiths Regarding Interchangeability/ Substitutability of SEBs dated 29 July 2010
Health Canada Does Not Support
Automatic Substitution
© 2016 Amgen Inc. All rights reserved.

12. Opportunity to Educate Stakeholders on
Biosimilars
Source. The Arthritis Society SEB Survey, November 2015
TAS Survey of >650 Individuals
Touched by Arthritis
SERMO Survey of 1,201 physicians
knowledge about Biosimilars
The
survey
showed
5
major
gaps
in
the
knowledge
of
many
physicians:
1. Defining
biologics,
biosimilars
and
biosimilarity
2. Regulatory
approval
process
3. Safety
profile
requirements
4. Determining
extrapola-on
5. Defining
interchangeability
© 2016 Amgen Inc. All rights reserved.
Source. Biosimilars Forum (US), October 2016

13. Biosimilars:
Appropriate
Place
in
Therapy
November
2016
Dawn
Richards,
PhD
Vice
President,
Canadian
Arthri2s
Pa2ent
Alliance

14. What
is
CAPA?
• Virtual,
pa2ent-­‐driven,
na2onal
arthri2s
advocacy
organiza2on
• About:
educa2on,
awareness,
collabora2on
&
advocacy
• Find
us
at:
www.arthri2spa2ent.ca
www.facebook.com/CAPA.Aca
@CAPA_Arthri2s

15. CAPA
Believes
• The
first
expert
in
arthri2s
is
the
person
living
with
arthri2s.
• People
with
arthri2s
have
the
right
and
responsibility
to
be
included
in
the
policy,
health
care
and
research
decisions
related
to
their
health
and
quality
of
life.
“Those
affected
by
the
decision
must
be
involved
in
making
the
decision”

16. Our
Posi-on
on
Biosimilars

17. Health
Canada
states:
‘Subsequent
Entry
Biologics
are
not
“generic”
biologics.
Authoriza2on
of
an
SEB
is
not
a
declara2on
of
pharmaceu2cal
or
therapeu2c
equivalence
to
the
reference
biologic
drug.’
www.hc-­‐sc.gc.ca/dhp-­‐mps/brgtherap/applic-­‐demande/guides/seb-­‐pbu/seb-­‐pbu_2010-­‐eng.php#int

18. Ourposition: 1
Biosimilars
have
a
role
to
play
in
providing
addiDonal
treatment
opDons
for
paDents
and
potenDal
cost
savings
to
drug
reimbursement
programs
only
if
prescribed
appropriately
following
clinically-­‐approved
guidelines.

19. Ourposition: 2
Biosimilars
must
not
be
considered
for
automaDc
subsDtuDon
or
interchangeable
with
the
reference
biologic
PaDents
should
not
be
forced
to
switch
from
one
therapy
to
another
when
they
are
well
managed
on
their
current
medicaDon.
Treatment
decisions
need
to
be
discussed
and
agreed
upon
between
the
physician
and
paDent
based
on
the
best
available
evidence
with
the
best
health
outcome
for
paDents
as
the
primary
goal.

20. Ourposition: 3
Biosimilars
should
have
unique
and
disDnct
names
to
ensure
no
accidental
subsDtuDon
by
the
pharmacy.
This
will
ensure
conDnued
post-­‐market
surveillance
of
adverse
drug
reacDons
for
the
correct
drug.

21. Ourposition: 4
Biosimilars
should
be
subject
to
rigorous
Health
Technology
Assessment
and
to
post-­‐approval
safety
and
efficacy
monitoring.

22. Ourposition: 5
Biosimilars
should
not
be
fast-­‐tracked
through
the
drug
review
process,
that
is,
being
reviewed
before
other,
possibly
more
criDcal
drugs
that
have
been
placed
in
a
queue
simply
due
to
economic
reasons.

23. Ourposition: 6
Biosimilar
manufacturers
should
be
encouraged
to
put
in
place
paDent
support
programs
similar
to
those
that
exist
for
reference
biologic
medicaDons.
These
programs
employ
trained
professionals
to
answer
any
quesDons
paDents
may
have
about
these
complex
drugs.
This
type
of
support
is
criDcal
for
paDents
to
feel
comfortable
about
and
confident
in
taking
their
medicaDon.

24. Ques2ons?
Contact
Dawn
Richards
Vice
President
of
CAPA
dawn.richards@arthri2spa2ent.ca

25. Pa-ents’
Knowledge
and
Beliefs
about
Biosimilars
Durhane
Wong-­‐Rieger,
PhD
Consumer
Advocare
Network

26. Patient Survey on
Biosimilars
§ WHAT is current status of biosimilars?
– Increasing number of biosimilars approved and available for
use
– Increasing evidence about safety, effectiveness, and quality
– Uncertainty about long-term outcomes and interchangeability
§ WHY were patients surveyed about biosimilars?
– Learn patient knowledge, beliefs, and opinions about
biosimilars
– Identify sources of patient and public information
– Engage patients to contribute to evolving understanding of
biosimilars
§ HOW will learning from survey be used to engage patients?
– Develop up-to-date information accessible by patients and
public
– Assure balanced approach to promote informed decision
making
26

27. How was Survey
Implemented
§ Canada-wide Web-based survey
– Conducted by Advocare and Canadian Organization for Rare Disorders
– Directed to existing patient cohort of 2,000+
– Secondary distribution to patient organizations and umbrella associations
– Promoted through Facebook and Twitter
§ Patient characteristics (Preliminary May-June 2016)
– Respondents = 320; Complete survey = 200
– Conditions = inflammatory, blood, immune-related, diabetes, cancers,
multi-systemic, lysosomal storage, heart, pulmonary
– Use biologics: 54% current, past or future; 24% not likely, 22% not aware
– Familiar with definition: 44% unfamiliar; 36% somewhat; 20% very
– Sources for information on biosimilars: 62% Web, 38% forum; 32% media;
25% clinician (note: respondents could pick more than one)
27

28. Patient Perceptions of Biosimilars
16%
24%
40%
8%
16%
27%
19%
18%
8%
16%
57%
57%
42%
84%
68%
0%
20%
40%
60%
80%
100%
120%
OK
to
use
if
NOT
on
original
Be
unwilling
to
switch
Should
accept
if
"much
cheaper"
Could
have
other
adverse
effects
Could
expect
different
response
Disagree
Neither
Agree
28
To
what
degree
do
you
agree
a
biosimilar
as
compared
to
the
original
…?

29. Patient Perceptions of
Biosimilars
48%
78%
50%
6%
18%
24%
4%
8%
22%
6%
24%
28%
96%
14%
28%
88%
58%
0% 20% 40% 60% 80% 100%
Encourage switching if cheaper
Patient right to informed choice
Recommend patient be switched
Approve biosimilar if originator
NOT approved
Assure NO interchangeability
Approve more biosimilars
Disagree Neither Agree
29
Should
government
regulator,
drug
plan,
HTA,
or
payer
do
following?

30. Summary Patient Attitudes re:
biosimilars
30
40%
believe
may
subs2tute
a
biosimilar
for
the
originator
40%
believe
should
NOT
subs2tute
40%
believe
pa2ents
should
accept
a
biosimilar
if
much
cheaper
40%
believe
price
should
NOT
be
a
factor
About
60%
would
be
UNWILLING
to
switch
from
the
originator
to
a
biosimilar
60%
say
okay
to
prescribe
a
biosimilar
to
NEW
pa2ents
About
60%
would
be
UNWILLING
to
switch
from
the
originator
to
a
biosimilar
60%
say
okay
to
prescribe
a
biosimilar
to
NEW
pa2ents
About
90%
say
drug
plans
should
assure
NO
interchangeability
Almost
80%
say
governments
should
NOT
recommend
switching
from
the
originator
to
a
biosimilar
Almost
100%
say
pa2ents
have
the
right
to
informed
consent
Almost
half
say
governments
should
NOT
encourage
switching
on
the
basis
of
“cheaper”
cost;
about
a
quarter
agree
should
encourage
switching
based
on
cost

31. Contact:
Durhane Wong-Rieger
Consumer Advocare Network
www.consumeradvocare.org
416-969-7435
durhane@sympatico.ca