EU: Biosimilars – A Success Story! A presentation by Conrad Savoy at Pharma Integrates 2013, an event for senior management in the pharmaceutical industry created and run by Life Sciences Index.

1. EU: Biosimilars – A Success Story!
EU Regulatory Framework
– In
place
since
2006
and
further
expanded
– Product
class
specific
guidelines
developed
– Immunogenicity
guidelines
– Overarching
guidelines
presently
under
revision
Ø 17
biosimilars
authorized
(2
MAbs)
Ø Learning
Insights
Ø «Case
by
case
decision»
Ø «Stepwise
approach»
Copyright
©
2013
Conrad
SAVOY,
PhD,
MBA
conradsavoy@hotmail.com
1

2. EU: Revision of Overarching
Guidelines for Biosimilars (1)
Additional guidance in five main areas
– Risk-­‐based
approach
for
the
design
of
non-­‐clinical
studies
– Use
of
PD
markers
in
support
of
clinical
comparability
– Efficacy
trial
design
(non-­‐inferiority
versus
equivalence)
• Choice
of
an
appropriate
pa[ent
popula[on
• Choice
of
surrogate
endpoints
– Design
of
immunogenicity
studies
– Extrapola[on
of
efficacy
and
safety
from
one
therapeu[c
indica[on
to
another
Copyright
©
2013
Conrad
SAVOY,
PhD,
MBA
conradsavoy@hotmail.com
2

3. EU: Revision of Overarching
Guidelines for Biosimilars (2)
Sourcing of reference product:
– Use
of
reference
products
sourced
from
highly
regulated
markets
outside
of
Europe
– Revised
dra
guideline
is
an
important
step
toward
global
development
of
biosimilars:
• Avoid
repeat
clinical
trials
which
do
not
serve
any
scien[fic
purpose
(unethical)
• Limit
development
costs
for
biosimilars
of
>
EUR
100
-­‐
200
which
otherwise
would
almost
double
Copyright
©
2013
Conrad
SAVOY,
PhD,
MBA
conradsavoy@hotmail.com
3

4. USA: Biosimilars – When does the
Story start?
Legal pathway in the US for the approval of biosimilars:
– Biologics
Price
Compe[[on
and
Innova[on
Act
(BPCI
Act)
of
2009
– The
BPCI
Act
signed
into
law
on
23
March
2010
– The
BPCI
Act
establishes
an
abbreviated
approval
pathway
for
biological
products
‘highly
similar’
(biosimilar)
to,
or
‘interchangeable’
with,
an
FDA
approved
biological
product
– FDA
has
yet
to
issue
finalized
prac[cal
guidance
(dra
guidance
2/2012
&
3/2013)
– Three
years
down
the
line
FDA
is
s[ll
awai[ng
its
first
biosimilar
applica[on
Copyright
©
2013
Conrad
SAVOY,
PhD,
MBA
conradsavoy@hotmail.com
4