GLO BA L B IO SIM IL A R S M ARK ET A bio sim ila r is alm ost an id en tic al co py of an orig in al pro duct th at is man ufa ctu re d by a dif fe re n t co m pan y when th e pate n t of th at bio lo gic

GLO BA L B IO SIM IL A R S M ARK ET
 
A bio sim ila r
is
alm ost
an
id en tic al
co py
of
an
orig in al
pro duct
th at
is
man ufa ctu re d
                           
by
a dif fe re n t
co m pan y
when
th e
pate n t
of
th at
bio lo gic 's
fo rm ula
is
no
lo nger
                           
pro te cte d ,
multip le
co m pan ie s
can
re le a se
a dru g
with
th e
sa m e
ch em ic al
re cip e,
                       
driv in g
th e
co st
dow n,
th at
new
bio lo gic
dru g
is
a bio sim ila r.P ate n ts
of
bio lo gic
                         
dru gs
of
majo r
pharm ace u tic als
co m pan ie s,
su ch
as
Lan tu s,R em ic ad e,
Rit u xan ,
                 
Herc ep tin ,
Enbre l,
an d
oth ers
hav e
ex pir e d
re cen tly
an d
in
th e
co m in g
decad e,
                       
Pate n ts
fo r
man y
bra n ded
bio lo gic s
will
ex pir e
durin g
th e
nex t
fe w
years
su ch
as
                           
Erb itu x,
Avastin ,
Ore n cia ,
an d
oth ers ,
whic h
would
pro vid e
th e
av aila b ili ty
of
                     
bio sim ila rs
becau se
th ese
ag en ts
are
ex pecte d
to
im pro ve
affo rd ab ili ty
an d
pro m ote
                     
wid er
an d
earlie r
acc ess
to
critic al,
ofte n
lif e sa v in g
th era p eu tic
in te rv en ti o ns.
                   
Id eally ,
th e
FD A’s
fin aliz e d
guid elin es
will
esta b lis h
a re g ula to ry
path
fo r
                     
bio sim ila rs
th at
will
en su re
pati e n t
sa fe ty ,
co ntr o l
dev elo pm en t
co sts ,
an d
                   
en co ura g e
in novatio n
by
man ufa ctu re rs
an
opportu nit y
fo r
man y
new
co m pan ie s
as
                     
well
as
gen eric
man ufa ctu re rs
to
off e r
se rv ic es,
sp ecia ll y
ta ilo re d
to w ard
                   
bio sim ila rs .
The
glo bal
bio sim ila r
mark et
has
bee n
valu ed
to
be
3,4 74.0 1
mil li o n
                       
USD
in
2017,
an d
is
ex pecte d
to
ris e
at
th e
CA GR
of
43.8 5%
durin g
th e
perio d
of
                                 
nex t
5 years
(2 018-2 023).
North
Am eric a
has
been
pre d ic te d
to
acco unt
fo r
th e
                         
la rg est
sh are
of
ap pro xim ate ly
30%
of
th e
glo bal
mark et,
in
2017,
while
                       
Asia -P acif ic
re g io n
is
an ti c ip ate d
to
re g is te r
th e
hig hest
CA GR
over
th e
fo re c ast
                       
perio d.M ark et
gro w th
an d
co m petit iv e
pre ss u re s
fo r
Bio sim ila rs
may
vary
fr o m
                   
co untr y
to
co untr y ,
alo ng
with
bein g
a pote n tia l
nic h e
lo w -c o st
pow er
in
                       
unre g ula te d
an d
se m i- re g ula te d
mark ets ,
In dia n
co m pan ie s
are
gearin g
to
ad opt
                   
guid elin es
more
in
lin e
with
th e
US
or
Euro pean
Unio n
(E U ).A s
more
an d
more
                           
In dia n
co m pan ie s
pass
th e
ap pro val
pro cesse s
in clu din g
ex te n siv e
cli n ic al
tr ia ls ,
                   
In dia
will
so on
em erg e
as
a str o ng,
re la tiv ely
lo w
co st
su pplie r
of
Bio sim ila rs
                         
pro ducts .
Valid atio n
of
bio sim ila rs
with
re fe re n ce
bio lo gic s
is
a im porta n t
asp ect
of
                       
th e
overa ll
pro cess
of
dev elo pm en t.
EM A
an d
FD A
whic h
are
th e
re g ula to ry
                       
au th oritie s
activ ely
re g ula te
th e
co m merc ia li z atio n
an d
dev elo pm en t
of
bio sim il a rs .
                 
The
fir s t
bio sim ila r
was
ap pro ved
an d
mark ete d
in
In dia
in
2000,
U.S .A
ap pro ved
                         
its
fir s t
bio sim ila r
in
2015
as
per
Gen eric s
an d
Bio sim ila rs
In iti a tiv e
(G aB I),
In dia
                         
th us
has
much
more
ex perie n ce
in
man ufa ctu rin g
bio sim ila r
an d
a re g ula to ry
                     
en vir o nm en t
bette r
th an
oth er
parts
of
th e
world .
               

In dia
has
a th riv in g
bio sim ila rs
mark et
with
66
ap pro ved
bio sim il a r
pro ducts
                     
av aila b le ,
while
Euro pe
has
31
bio sim ila rs
on
th e
mark et
an d
th e
US
has
5.
In dia
is
                               
em erg in g
as
an
im porta n t
pla y er
in
th e
glo bal
bio sim ila r
mark et.T he
key
ty pes
of
                         
Bio sim ila rs
Mark et
are
dev elo ped
mark ets
an d
em erg in g
mark ets .
Exam ple s
of
                   
dev elo ped
mark ets
are
th e
Unite d
Sta te s,
EU 5
an d
Ja p an .
In
em erg in g
mark ets ,
th e
                         
la rg e
pock ets
of
non co nsu m ptio n
an d
unta p ped
dem an d
ch ara c te riz ed
by
poor
                   
physic al
an d
fin an cia l
ac cess
to
cu rre n tly
hig h
pric ed
bio lo gic s
pro vid e
fa v ora b le
                     
lo ng-te rm
gro w th
oppo rtu nitie s
. ?Facto rs
driv in g
th e
glo bal
bio sim ila rs
mark et
are
                     
av aila b ility
of
med ic in es
at
25
to
40
perc e n t
lo w er
pric es
th an
orig in al
bra n ded
                         
pro ducts ,
ex pir e
of
ex is ti n g
pate n ts ,
ris in g
pre v ale n ce
of
ch ro nic
dis e a se s
su ch
as
                       
can cer
an d
dia b ete s,
hig her
pro bab ility
of
Retu rn
on
In vestm en t
th an
with
new
                       
pro duct
R; D.I n
2012,
In dia
dra fte d
th e
‘S im il a r
Bio lo gic s
Guid eli n e’
by
th e
                     
Cen tr a l
Dru gs
Sta n dard
Contr o l
Org an is a tio n
(C D SC O )
an d
th e
Dep artm en t
of
                   
Bio te ch nolo gy.B io sim ila rs
in
In dia
has
alr e a d y
att r a cte d
la rg e
in vestm en ts
in
are as
                   
of
re se arc h ,
clin ic al
tr ia ls
an d
?man ufa ctu rin g.
In
fu tu re ,
In dia n
mark et
will
als o
se e
                         
lo t
of
str a te g ic
partn ers h ip s
em erg in g
betw een
glo bal
an d
In dia n
co m pan ie s
to
                     
le v era g e
each
oth er's
pote n tia l.
The
In dia n
Bio sim ila rs
mark et
pro vid es
num ero us
                   
gro w th
an d
in vestm en t
opportu nit ie s
fo r
In dia n
an d
Fore ig n
pla y ers
In
August
                     
2016,
CD SC O
mad e
so m e
re v is io ns
to
th e
co untr y ‘s
bio sim il a r
guid elin es.
                   
Bio sim ila r
th era p eu tic
pro ducts
in
In dia
co nsis t
prim arily
of
vacc in e
(H ep atit is
B                     
vaccin e),
monoclo nal
an ti b odie s,
re co m bin an t
pro te in s
an d
dia g nostic s,
in su li n ,
               
ery th ro poie tin ,
gra n ulo cy te
co lo ny
stim ula tin g
fa cto r,
str e p to kin ase ,
in te rfe ro n
             
alp ha-2 B ,
Ritu xin ab ,
ep id erm al
gro w th
fa cto r
re ce p to r,
ch orio nic
gonad otr o pin
an d
                 
hep arin .
In dia n
pharm a
co m pan ie s
are
now
mak in g
sig nif ic a n t
in vestm en ts
in to
                   
bio sim ila r
dev elo pm en t
an d
pro ductio n
in
an
att e m pt
to
se cu re
th e
early
mover
                       
ad van ta g e
an d
in cre asin gly
partn erin g
with
weste rn
co unte rp arts
to
la u nch
a                   
gre ate r
num ber
of
bio th era p eu ti c s
in
both
lo ca l
an d
in te rn ati o nal
mark ets .I n
2013,
                     
Roch e
te am ed
up
with
Em cu re
Pharm aceu tic als
to
man ufa ctu re
Herc e p tin
in
In dia
                     
afte r
its
pate n t
ex pir e
an d
se ll
at
a re d uced
pric e
in
under
a dif fe re n t
nam e
with
th e
                                 
in te n t
of
main ta in in g
its
str o ng
mark et
sh are .
In dia n
fir m s
are
usin g
dif fe rin g
                       
str a te g ie s
to
su sta in
in
bio sim ila r
mark et,
i,e .,
so m e
doin g
in
house
re se arc h
while
                         
oth ers
are
atte m ptin g
to
lo w er
ris k
by
ta k in g
th e
lic en sin g
ro ute .
A lo t
of
                           
co m pan ie s
hav e
em erg ed
in
th e
pro ductio n
of
bio sim ila rs
an d
hav e
been
ch an gin g
                       

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th e
fa ce
of
pharm aceu tic al
mark et,
in
se arc h
of
im pro v ed
quali ty
bio sim ila rs
so m e
                       
of
th em
are
Novartis ,
Cell tr io n
In c.
, Am gen ,
Bio gen ,
Merc k
& Co.
,C oheru s
                         
Bio S cie n ces
In c
etc .
In clin atio n
to w ard s
bio sim ila rs
has
in cre ase d
aro und
th e
                   
world
an d
In dia
has
str o ng
pote n ti a l
to
em erg e
as
a key
pla y er
in
th e
man ufa c tu re
                             
an d
mark etin g
of
bio sim ila rs
with
its
la rg e
co nsu m er
base .
New
re g ula to ry
polic y
                       
an d
in cre ase d
affo rd ab ility
has
le a d
th e
dom esti c
mark et
to
gro w
at
an
acc ele ra te d
                         
pace
an d
re ach
th e
ta rg et
of
$40
billio n
by
2030
with
20 %
sh are
in
glo bal
mark et.
                               
There
is
need
to
dev elo p
well- d esig ned
cli n ic al
tr ia l
guid eli n e
to
esta b lis h
sa fe ty
                       
an d
to
pro m ote
co nfid en ce
in
th e
new
bio sim ila r
pro ducts
in
In dia .
Curr e n tly ,
both
                         
man ufa ctu re s
an d
re g ula to rs
are
str e n gth en in g
up
?to
meet
th e
fu tu re
ch alle n ges.
                     
Bio sim ila rs
are
th e
fu tu re
hope
to
im pro ve
can ce r
tr e a tm en t
acce ss
in
lo w –
an d
                         
mid dle
in co m e
gro up
patie n ts .
Curr e n tly
most
of
th e
lu cra tiv e
pro ducts
in
                     
bio sim ila rs
in dustr ie s
are
monoclo nal
an ti b odie s,
G-C SF
ery th ro poie tin
an d
               
pep tid e.
?In
In dia
bio sim ila rs
hav e
att r a cte d
la rg e
in vestm en ts
in
re se arc h ,
cli n ic al
                     
tr ia ls
an d
man ufa ctu rin g.
In
fu tu re ,
partn ers h ip s
will
em erg e
betw ee n
glo bal
an d
                     
In dia n
co m pan ie s
to
in cre a se
pote n tia l
of
bio sim ila rs
mark et.
In dia n
co m pan ie s
                   
are
in cre asin gly
partn erin g
with
in te rn atio nal
pharm aceu tic al
gia n ts
in
ord er
to
gain
                     
access
to
dev elo ped
mark ets
in
th e
lo ng-te rm ,
dev elo p
an d
mark et
Bio sim ila rs
                     
pro ducts .
?In clin atio n
to w ard s
bio sim ila rs
has
in cre a se d
aro und
th e
world .
In
Bra zil
                     
dev elo pm en t
of
bio sim ila rs
le d
to
fo rm atio n
of
re g ula tio ns
in
Latin
Am eric a
an d
                       
re le ase d
bio sim ila rs
guid an ce
in
2010,
re d ucin g
th e
re lia n ce
on
im porte d
an d
                     
hig h-c o st
med ic in es
th ro ugh
polic ie s
th at
fa v or
th e
ex pan sio n
of
th e
dom esti c
                     
pharm aceu tic al
in dustr y
an d
public
priv ate
partn ers h ip s
to
ex pan d
acce ss
to
dru gs.
                     
In te rn atio nal
co m pan ie s
hav e
en te re d
th e
mark et
th ro ugh
partn ers h ip s
an d
                 
acq uis itio ns
e.g .,
Pfiz er’s
40%
sta k e
in
Teu to ,
San ofi’ s
acq uis iti o n
of
Med le y
an d
                       
Merc k ‘s
jo in t
ven tu re
with
Supera ,
co -o w ned
by
Cris ta lia
an d
Euro fa rm a
The
                     
re g ula to ry
en vir o nm en t
an d
in te re st
of
dom esti c
an d
in te rn ati o nal
man ufa c tu re rs
                 
are
majo r
driv ers
in
ex pan din g
th e
bio sim ila rs
mark et.
Appro xim ate ly
fiv e
                   
bio sim ila r
mole cu le s
in
th e
dev elo pm en t
pip elin e.
Russ ia
aim s
to
boost
it s
                     
dom estic
pharm aceu tic a l
mark et
an d
in cre a se
th e
mark et
sh are
of
dom esti c
pla y ers
                     
fro m
20%
in
2012
to
50%
by
2020
,t h e
str o ng
pre fe re n ce
fo r
lo ca l
man ufa c tu re rs
                           
will
re q uir e
in te rn atio nal
co m pan ie s
to
en gag e
in
co opera tiv e
partn ers h ip s
with
                   
Russia n
co m pan ie s
th us
In dic ativ e
of
th e
burg eo nin g
dom esti c
in dustr y ,
a                   

ritu xim ab
bio sim ila r,
dev elo ped
by
Russ ia n
co m pan y
Bio ca d ,
was
th e
fir s t
mAb
                     
bio sim ila r
ap pro ved
in
Russ ia
in
April
2014,
ab out
eig ht
bio sim il a r
mole cu le s
are
                       
in
th e
dev elo pm en t
pip elin e.
Mex ic o
esta b lis h ed
a govern m en t- in cen tiv iz e d
mark et
                 
fo r b io sim ila rs a n d i ts d em an d s p urre d b y h ig h o ut- o f-p ock et h ea lth c are s p en din g.
 
South
kore a
is
th e
most
matu re
bio sim ila r
“d ev elo pm en t”
mark et
en ab le d
by
                     
unpre ced en te d
su ppo rt
fro m
th e
South
Kore an
govern m en t,
35%
of
th e
nati o nal
                     
med ic al
R; D
budget
was
in veste d
in to
bio sim ila rs
dev elo pm en t
in
2012.
                   
Govern m en t- s e t
goal
fo r
dom esti c
bio
pharm ace u tic al
co m pan ie s
to
win
22%
of
                     
th e
glo bal
bio sim ila rs
mark et
by
2020.
Tw elv e
bio sim ila rs
hav e
been
ap pro ved
an d
                       
an oth er
36
bio sim ila rs
are
in
th e
pip elin e
. In
South
afric a
gen eric s
mak e
up
more
                             
th an
50%
of
th e
mark et
.B io sim ila rs
guid elin es
were
esta b lis h ed
in
2010,
se v era l
                       
In dia n
co m pan ie s
hav e
en te re d
th e
South
Afric a n
mark et
an d
are
key
to
keep in g
                         
dru g
co sts
lo w .
Com pan ie s
will
hav e
to
brin g
in
a co st
str u ctu re
th at
is
lo w er
th an
                               
what
cu rre n tly
ex is ts
alo ng
with
th e
hig hest
quali ty
an d
sa fe ty
pro file s
of
th eir
                         
bio sim ila rs .
Chin a
is s u ed
dra ft
bio sim ila rs
guid elin es
in
2014
once
a cle ar
                     
re g ula to ry
path w ay
fo r
bio sim ila r
ap pro val
is
esta b lis h ed ,
th e
mark et
will
be
very
                       
attr a ctiv e
due
to
th e
volu m e
pote n tia l
, gro w in g
ab il it y
to
pay .
Sim ila r
to
th e
tig ht
                             
co ntr o ls
re q uir in g
in te rn atio nal
co m pan ie s
to
cre a te
partn ers h ip s
or
use
dom esti c
                   
pharm aceu tic al
dis tr ib uto rs ,
th e
su ccessfu l
man ufa ctu rin g
an d
mark etin g
of
               
bio sim ila rs
will
als o
re q uir e
partn ers h ip s
with
dom estic
co m pan ie s.
Lack
of
                   
physic ia n
tr u st
an d
en th usia sm
fo r
non-b ra n ded
dru gs
ex ace rb ate d
by
unsa fe
an d
                     
co unte rfe it d ru gs.
 
Facto rs
th at
lim it
mark et
gro w th
of
bio sim ila rs
are
la c k
of
re g ula to ry
                     
guid elin es,c o nsu m ers
bra n d
pre fe re n ces,r e lu cta n ce
of
physic ia n s
to
pre sc rib e
             
bio sim ila rs ,t h e
hig h
cap ita l
re q uir e d
fo r
re se arc h
an d
dev elo pm en t.
Alth ough
it
is
                     
gen era lly
ex pecte d
th at
bio sim ila rs
will
em erg e
as
a ra p id ly
gro w in g
se g m en t
of
                       
th e
bio pharm aceu tic al
in dustr y ,
th eir
upta k e
fa ces
se v era l
ch alle n ges
. Desp ite
th eir
                     
pro m is e ,
bio sim ila rs
fa ce
co m petit io n
fro m
non-o rig in al
bio lo gic s
an d
bio -b ette rs :
                 
Reg ula to ry
uncerta in ty ,
Pro ductio n
co m ple x it y ,
The
re g u la to ry
poli c ie s
govern in g
               
bio sim ila rs
are
still
in
flu x,
with
majo r
mark ets
lik e
Chin a
la ck in g
co nsis te n t
an d
                         
cle ar
path w ay s.
The
Unite d
Sta te s
is s u ed
dra ft
bio sim il a rs
guid an ce
in
2013,
an d
                       
alth ough
th e
FD A
re ce n tl y
ap pro ved
th e
filg ra stim
bio sim il a r,
th e
ag en cy
has
yet
                       

to
fin aliz e
a fo rm al
ap pro val
path w ay .
Unlik e
gen eric s,
th e
co st,
ti m e,
an d
ris k
of
                           
bio lo gic s
pro ductio n
are
hig her,
an d
th ese
are
ty pic ally
passe d
on
to
th e
co nsu m er
                         
in
te rm s
of
hig her
pric e s.
While
gen eric s
co st
betw een
$1
mil li o n
an d
$5
mil li o n
to
                             
dev elo p,
bio sim ila rs
co st
betw een
$100
mil li o n
an d
$200
mil li o n.v ii
Bio sim il a rs
                   
are
more
co m ple x
to
dev elo p
an d
man ufa ctu re
due
to
th e
in here n t
varia b ili ty
                       
betw een
one
liv in g
ce ll
an d
an oth er,
an d
th e
in ab ili ty
to
ex actly
re p li c ate
th e
                         
man ufa ctu rin g
or
str u ctu re
of
th e
orig in ato r
bio lo gic .
In te rc h an geab il it y
               
Com petitio n
The
la ck
of
cle ar
guid elin es
on
su bstitu ta b il it y
an d
in te rc h an geab il ity
                   
with
re fe re n ce
bio lo gic s
will
lik ely
cau se
physic ia n s
to
ex erc is e
more
cau tio n
in
                       
pre sc rib in g
bio sim ila rs
until
th ey
gain
co m fo rt
with
th e
quali ty
an d
effic ac y
of
                       
bio sim ila rs .
When
th e
FD A
re v ie w ed
San doz’s
filg ra stim ,
th ere
was
much
                   
sp ecu la tio n
on
wheth er
in te rc h an gea b ility
would
be
re co m men ded .
How ev er,
th e
                 
FD A
only
fo cu se d
on
bio sim ila rity .
This
mean s
th at
San doz
may
need
to
sh ow
                         
co m para tiv e
data
an d
en gag e
in
mark et
ed ucati o n
to
driv e
pre sc rip ti o ns
an d
                     
in cre ase
mark et
sh are .
Bio sim ila rs
fa ce
co m peti ti o n
fro m
at
le ast
tw o
so urc e s:
                     
bio bette rs
fro m
bra n ded
co m pan ie s
an d
bra n d
co nsc io usn ess
fro m
co nsu m ers .
                 
Bio sim ila rs
are
an tic ip ate d
to
en gag e
prim arily
in
“b ra n d-o n-b ra n d”
co m petit io n
                 
with
th eir
re fe re n ce
th era p ie s,
unlik e
Hatc h -W ax m an
gen eric s.
Als o
unli k e
                 
gen eric s,
whic h
are
heav ily
dis c o unte d ,
bio sim ila r
dis c o unts
can
be
off s e t
by
                     
re b ate s
an d
se rv ic e
ag re em en ts
fo r
bra n ded
bio lo gic s,
th ere b y
mak in g
bio sim il a rs
                   
le ss
attr a ctiv e.
With
more
so phis tic ate d
an d
lo ng-te rm
bio lo gic
tr e a tm en ts
(e .g .,
                   
monoclo nal
an tib odie s
an d
gro w th
horm ones)
an d
th e
asso cia te d
tr e atm en t
                 
ch ro nic ity ,
it
co uld
ta k e
lo nger
to
dem onstr a te
an d
co nvin ce
sta k eh old ers
of
th e
                       
ben efits o f s w itc h in g.
 
 
 
 
 
 
 
 

While
bio sim ila rs
gro w th
pote n tia l
ap pears
brig ht,
win nin g
with
bio sim il a rs
in
                   
em erg in g
mark ets
is
not
a sim ple
underta k in g.
Com pan ie s
se ek in g
en tr y
or
                     
ex pan sio n
sh ould
cra ft
a str a te g y
to
ad dre ss
th e
sp ecif ic
ch alle n ges
in
th e
em erg in g
                         
mark ets
an d
in co rp ora te
th e
le sso ns
le a rn ed
fr o m
dev elo ped
mark ets .
A uniq ue
                     
valu e
pro positio n
will
lik ely
be
re q uir e d
to
ta p
in to
th e
la rg e
popula tio ns
in
                         
em erg in g
mark ets
who
can not
acce ss
hig h-p ric e d
bio lo gic s.
These
co m pan ie s
                 
sh ould
dev elo p
ro bust
mark et- a ccess
str a te g ie s
an d
sh ould
be
pre p are d
to
mak e
                     
upfro nt
in vestm en ts
to
driv e
ad opti o n,
an d
sh if t
busin ess
models
fr o m
pro fit
to
                       
volu m e.
Upfro nt
in vestm en ts
will
lik ely
re q uir e
a str o ng
em phasis
on
physic ia n
                     
an d
patie n t
ed ucatio n
to
ad dre ss
non-c o nsu m ptio n,
as
well
as
su pply
ch ain
                     
in vestm en ts
to
bette r
en ab le
acce ss
to
th e
med ic atio n.
Part
of
th is
ed uca tio n
may
                         
co m e
th ro ugh
th e
sa le s
fo rc e ,
who
sh ould
be
fu lly
eq uip ped
to
meet
th e
need s
of
                             
th e
patie n t.
Fin ally ,
man ufa c tu re rs
sh ould
work
with
lo cal
pla y ers
to
help
nav ig ate
                       
th e
know le d ge
of
lo cal
mark et
nuan ces
an d
le a n ,
lo w -c o st
man ufa c tu rin g,
co uple d
                     
with
th e
str o ng
in te rn atio nal
bra n d
an d
re p uta tio n
of
th e
man ufa ctu re r,
will
help
to
                         
pro pel t h e g ro w th o f b io sim ila rs i n e m erg in g m ark ets .
 

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