Expert Patient Advocates & 21st Century Therapies Forum Nov 19 - 20, 2015

1. Biosimilars/Subsequent
Entry
Biologics:
Innova9ons
and
Challenges
Michael S. Reilly, Esq.
Executive Director, Alliance for Safe Biologic Medicines
Presented at the Expert Patient Advocates & 21st Century Therapies Forum
November 19, 2015
Toronto, ON

2. About
The
Alliance
for
Safe
Biologic
Medicines
(ASBM)
Harry
L.
Gewanter,
MD,
FAAP,
FACR:
Chairman,
pediatric
rheumatologist
Philip
Schneider:
Dean,
University
of
Arizona
College
of
Pharmacy-­‐
Advisory
Board
Chair
Michael
Reilly,
ExecuJve
Director
michael@safebiologics.org
• Steering
CommiMee
composed
of
paJent
and
physician
groups.
• Advisory
Board
of
physicians,
researchers,
pharmacists,
and
paJents.
2
STEERING COMMITTEE

3. “The
Four
Pillars”
PRIORITIZING
PATIENT
SAFETY
LEVERAGING
WHAT WE HAVE
LEARNED
PROMOTING
PHARMACO-
VIGILANCE
KEEPING
HEALTHCARE
PROVIDERS
RELEVANT
ASBM’S GUIDING PRINCIPLES

4. 4
Biologic
vs.
Chemical
Medicines
SIZE:
significantly
larger,
potenJal
for
immunogenic
reacJons
STRUCTURE:
more
complex,
cannot
be
completely
characterized
or
copied
STABILITY:
suscepJble
to
light,
heat,
denaturing
/
degradaJon
SENSITIVITY:
even
small
manufacturing
changes
can
cause
changes
in
efficacy
and/
or
adverse
effects
DRIFT:
can
change
with
Jme

6. Biosimilars/SEBs:
A
Medical
Innova9on

7. Benefits
of
Biosimilars/SEBs
for
Pa9ents
• Increased
therapeuJc
opJons
– More
treatment
choices
for
physician
and
paJent.
• Cost
savings
over
reference
biologics:
– Unlike
generics,
which
save
40-­‐80%,
due
to
higher
development
costs
biosimilars
are
expected
to
save
payers
15-­‐30%1
1. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(3-4).120-6. DOI: 10.5639/gabij.2012.0103-4.036

8. Challenges
of
Bringing
Biosimilars
to
Pa9ents
• FDA’s
Dr.
Janet
Woodcock,
spoke
this
week
regarding
the
challenges
of
introducing
biosimilars,
saying:
There
will
be
a
phase
[in]
of
acceptance,
or
perhaps,
partly
rejec9on,
from
the
medical
community,”
• Success
will
be
related
to
the
degree
of
physician
comfort
with
biosimilars.
Dr. Janet Woodcock,
Director of the Center
for Drug Evaluation
and Research (CDER)
at the U.S. (FDA)

9. Building
Physician
Confidence
• ASBM
has
engaged
with
the
physician
community
through
surveys
and
ConJnuing
EducaJon
courses.
• Goal:
to
build
physician
confidence
in
biosimilars,
so
that
physicians
can
confidently
prescribe,
or
switch
paJents
to
biosimilars.
• However,
recogniJon
of
the
differences
between
biosimilars
and
generics
have
resulted
in
physician
cauJon
regarding
biosimilar
adopJon.

10. Gathering
the
Perspec9ves
of
Biologic
Prescribers
Around
the
World
U.S.
Physician
Surveys
(September
2012):
376
physicians
(February
2015):
400
physicians
(Labeling)
(November
2015*):
400
physicians
E.U.
(France,
Italy,
Spain,
UK)
Physician
Survey
(November
2013):
470
physicians
Canadian
Physician
Survey
(December
2014):
427
physicians
U.S.
Pharmacist
Survey
(September
2015)
401
pharmacists
La9n
America
(Argen9na,
Brazil,
Colombia,
Mexico)
Physician
Survey
(May
2015):
399
physicians
All
surveys
available
at
www.SafeBiologics.org
*Tena9ve
release
date

11. 11
November
2014:
Presented
European
Survey
Data
to
Spanish
Health
Ministry
December
2014:
Presented
Canadian
Physician
Survey
data
to
Health
Canada
May
19,
2015:
Shared
U.S.
data
and
recommendaJons
with
U.S.
Dept.
of
Health
and
Human
Services
and
other
AdministraJon
officials
April
13,
2015:
ParJcipated
in
60th
WHO
ConsultaJon
on
InternaJonal
Nonproprietary
Names
(INN)
June
2015:
ParJcipated
in
WHO
Frontpage
MeeJng
to
finalize
the
Biologic
Qualifier
(BQ)
proposal.
October
13:
ParJcipated
in
the
61th
WHO
INN
ConsultaJon
October
14:
Presented
LaJn
American
survey
data
at
BIO
LaJn
America
Conference
in
Brazil
Recent
ASBM
AcCvity
Sharing
Findings
with
Na9onal
and
Interna9onal
Regulators

12. Issues
Regulators
Need
to
Address
• Assess
need
for
clinical
data,
as
it
relates
to
approval
and
indicaJon
extrapolaJon.
• What
data
do
physicians
want
to
see
in
order
to
feel
comfortable
prescribing?
– Physicians
want
informaJon
not
only
on
adverse
events,
but
data
which
demonstrate
successful
clinical
use
of
biosimilars
(post-­‐market
data)
• Assurance
of
transparency,
in
naming
and
labeling-­‐
what
the
product
is
and
how
it
became
approved.

13. PHYSICIAN
SURVEY
FINDINGS

14. 14
Indica9on
Extrapola9on:
A
Key
Concern
80%
of
physicians
considered
it
important
for
label
to
show
whether
approval
for
an
indicaJon
was
based
on
DATA
or
EXTRAPOLATION:
• ExtrapolaJon
remains
a
concern
for
physicians
and
paJent
groups.
• Both
want
some
assurances
that
clinical
data
used
for
one
disease
area
can
be
applied
to
demonstrate
efficacy
in
another.

15. 15
Recent
ASBM
AcCvity
Timeline:
Biologic
Naming
• July
2014:
WHO
Proposes
its
“Biological
Qualifier”-­‐
a
4-­‐leMer
code
to
disJnguish
similar
biologics
from
each
other.
www.who.int
• August
2015:
U.S.
Food
and
Drug
AdministraJon
(FDA)
issues
Guidance
supporJve
of
and
compaJble
with
WHO’s
BQ.
www.fda.gov
• Both
call
for
similar
biologics
(including
biosimilars)
to
have
a
shared
root
name
(InternaJonal
Nonproprietary
Name/
INN)
followed
by
a
four-­‐leMer
suffix.
• Health
Canada
has
been
generally
supporJve
of
the
WHO
approach.

16. Widespread
Physician
Support
for
Dis9nguishable
Naming
16
94%
of
La9n
American
Physicians
consider
WHO’s
BQ
Proposal
to
be
“useful”
in
helping
pa9ents
receive
the
correct
medicine.
79%
of
Canadian
physicians
support
Health
Canada
issuing
dis9nct
names.
66%
of
US
physicians
(and
68%
of
US
pharmacists)
support
FDA
issuing
dis9nct
names.

17. Pharmacy-­‐Level
Subs9tu9on:
A
Global
Challenge

18. How
Important
is
No9fica9on
of
a
Biosimilar
Subs9tu9on?
18
87%
of
La9n
American
Physicians
consider
it
“very
important”
or
“cri9cal”
85%
of
Canadian
consider
it
“very
important”
or
“cri9cal”
80%
of
US
physicians
consider
it
“very
important”
or
“cri9cal”
77%
of
EU
Physicians
consider
it
“very
important”
or
“cri9cal”

19. Importance
to
Pa9ents
• PaJent
always
needs
to
be
informed
about
the
medicine
he/she
is
receiving
in
order
to
make
informed
choices
and
be
an
effecJve
partner
in
care.
• Physician
needs
to
be
aware
of
what
medicine
paJent
is
receiving
to
provide
proper
care.
• Accurate
paJent
record
must
be
kept
for
pharmacovigilance/post-­‐market
monitoring
for
adverse
events
and
efficacy
• Physicians
and
pharmacists
have
a
responsibility
to
the
paJent
and
to
the
larger
community
(other
healthcare
providers,
regulators,
manufacturers)
to
work
collaboraJvely
together
–
that
includes
clear,
Cmely
communicaCon.

20. Transparency
in
Labeling:
An
Emerging
Issue

21. March
6:
First
Biosimilar
Approved
in
U.S.
• Zarxio
(filgras9m-­‐sndz)
• Went
on
sale
September
3.
• 15%
discount
over
reference
product
• Not
“interchangeable”

22. 22
Concerns
Surrounding
Biosimilar
Labeling
Some
concerns
surrounding
insufficient
transparency
in
Zarxio’s
labeling:
• It
is
not
idenJfied
as
a
biosimilar.
• No
data
used
to
demonstrate
biosimilarity
is
included.
• Not
specified
for
which
indicaJons
approval
was
based
on
trial
data,
or
extrapolaJon.
• Data
from
innovator
product
is
not
idenJfied
as
such.
o
o
o
o
o
o
www.fda.gov/medwatch

23. What
Do
Physicians
Want
to
See
on
a
Biosimilar
Label?
23
These
items
were
consistently
rated
a
“4”
or
a
“5”-­‐
indicaJng
high
or
very
high
importance
in
a
February
2015
Survey
of
400
U.S.
physicians:
90%
-­‐
That
product
is
a
biosimilar
79%
-­‐
A
definiJon
of
biosimilarity
82%
-­‐
AnalyJcal
data
used
by
biosimilar
sponsor
to
demonstrate
its
similarity
to
its
reference
product
83%
-­‐
Clinical
data
used
to
demonstrate
biosimilar
is
highly
similar
to
reference
product
79%
-­‐
Post-­‐market
surveillance
data
on
the
biosimilar
77%
-­‐
Name
of
the
biosimilar's
reference
product
79%
-­‐
IndicaJons
for
which
the
originator
is
approved,
but
the
biosimilar
is
not
79%
-­‐
Clear
disJnguishable
reference
product
data
from
biosimilar
data
79%
-­‐
Clinical
similarity
data
including
immunogenicity
effects
80%
-­‐
Which
approved
indicaJons
were
actually
studied,
vs.
which
were
extrapolated
from
data
in
other
indicaJons?
79%
-­‐
Whether
or
not
the
biosimilar
is
interchangeable
with
its
reference
product

24. Summary
24
• Building
physician
confidence
is
essenJal
in
order
to
bring
the
innovaJons
of
biosimilars
to
paJents.
• Physicians
worldwide
support
the
use
of
disJnguishable
names
for
biologic
products.
• In
the
event
of
a
biosimilar
subsJtuJon,
physicians
worldwide
consider
it
very
important
to
know
the
exact
medicine
their
paJent
receives.
• Transparency
in
labeling
also
helps
providers
make
informed
decisions
and
promotes
confidence
in
biosimilars.
IndicaJon
extrapolaJon
is
of
parJcular
concern.

25. Thank
You
For
Your
Apen9on