Global Biosimilars Market Regulations & Pipeline Insight

Global Biosimilars Market Regulations & Pipeline Insight 2014 Report Highlights:
Market Overview
Detailed Regulatory Pathways For 12 Countries/Regions
Gloal !iosi"ilars Pipeline y Phase# $ndi%ation# Co"pany & Country
!iosi"ilars Pipeline' 2() in Develop"ent Phase
Ma*ority !iosi"ilars in Pre%lini%al Phase' () !iosi"ilars
Marketed !iosi"ilars y $ndi%ation# Co"pany & Country' 11+ !iosi"ilars
,he evolution o- iosi"ilars has %urrently rea%hed di--erent stages a%ross the world. Owing to
variale %larity in the guidelines and diverse regulatory pathways# various de-initions o-
iosi"ilars /or the roader group o- -ollow0on iologi%s1 have e"erged a%ross %ountries. ,ill
now the 2uropean region has the est0estalished -ra"ework -or iosi"ilars. ,he 34 is
%urrently al"ost aligned to the 2uropean standards. !iosi"ilars are also known as -ollow on
iologi%s in the 34 and suse5uent entry iologi%s in Canada# are iologi% produ%ts whi%h are
approved in a %ountry# whi%h has an areviated approval pro%ess -or iologi% produ%ts whi%h
re-eren%es an originator iologi% in the regulatory su"ission.
,he gloal iosi"ilars "arket is %ategori6ed into "ono%lonal antiody iosi"ilars /"7s1#
insulins# inter-erons# erythropoetins# -ilgrasti"# so"atropin and -olli%le sti"ulating hor"one
/F4H1. 7"ong the seg"ents o- the iosi"ilars "arket# the "ono%lonal antiodies /"7s1 and
insulin "arket would witness "a8i"u" growth# with these two seg"ents a%%ounting -or a
do"inant share o- "ore than 9:; o- the total gloal iosi"ilars "arket y 2:1<. 7dditionally#
with the "7s having one o- the strongest R&D pipeline in the iologi%s "arket# it is e8pe%ted
that "any new ne8t0generation te%hnologies whi%h would push "7 therapeuti%s into newer
areas su%h as solid tu"ours# %ardiovas%ular and neurologi%al disorders would e introdu%ed
into the "arket.
$n ter"s o- innovation in the iosi"ilars# it is "ost likely that the -uture "arket would
witness the introdu%tion o- -ollitropins# inter-erons and low "ole%ular weight heparins
produ%ts# in addition to "7s. 7lso# it is e8pe%ted that so"e phar"a%euti%al %o"panies %ould
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Global Biosimilars Market Regulations & Pipeline Insight
in%reasingly start -o%using on spe%i-i% therapeuti% %lasses ased on their %apa%ity to
"anu-a%ture and their strategi% -it.
7l"ost all the %ountries a%ross the gloe are %urrently e8perien%ing an in%rease in their
ageing population with a parallel in%rease in the in%iden%e o- %hroni% diseases. However# an
in%rease in the de"and -or high 5uality health%are is generally asso%iated with the issue o-
%ontrolling spiraling health%are e8penditure. =ith the regulated and strea"lined introdu%tion
o- iosi"ilars into the "arket# it is "ost likely that there would e an in%rease in the
a%%essiility and a--ordaility o- the "u%h in de"and iologi% "edi%ines. ,he ne8t -ew years
are likely to witness a new set o- %o"ple8 iosi"ilars produ%ts eing developed owing to a
signi-i%ant nu"er o- leading rands o- iologi% drugs losing their patents y 2:2:.
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Table of Contents
1. Global Biosimilars Market Outlook
1.1 Market Overview
1.2 Clinical Pipeline Insight

2. Global Biosimilars Market Dynamics
2.1 Favorable Market Parameters
2.2 Issues to be Discussed

3. Global Biosimilars Market Future Growth Opportunities

4. Reulatory !athways "or De#elopment $ Marketin o" Biosimilars
.1 !ustralia
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Global Biosimilars Market Regulations & Pipeline Insight
.2 Canada
." #urope
. $apan
.% India
.& Mala'sia
.( )audi !rabia
.* )ingapore
.+ )outh !,rica
.1- )outh .orea
.11 /urke'
.12 0)

%. Global Biosimilars !ipeline by !hase& 'n(ication& )ompany $
)ountry
%.1 0nknown
%.2 1esearch
%." Preclinical
%. Clinical
%.% Phase2-
%.& Phase2I
%.( Phase2I3II
%.* Phase2II
%.+ Phase2III
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Global Biosimilars Market Regulations & Pipeline Insight
%.1- Preregistration
%.11 1egistered

*. Markete( Biosimilars by 'n(ication& )ompany $ )ountry

+. ,uspen(e( $ Discontinue( Biosimilars !ipeline by !hase&
'n(ication& )ompany $ )ountry
(.1 4o Development 1eported
(.2 Discontinued
(." )uspended

-. )ompetiti#e .an(scape
*.1 !ctavis
*.2 !mgen
*." 5io6press /herapeutics
*. 5oehringer Ingelheim
*.% 5iocon
*.& 5io )idus
*.( Dong2! Pharmaceutical
*.* 7arvest Moon Pharmaceuticals
*.+ Inbiopro )olutions
*.1- M'lan
*.11 1eliance 8i,e )ciences
*.12 )ando9 International
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Global Biosimilars Market Regulations & Pipeline Insight
Figure 121: ;lobal 5iosimilars Market <0)= 5illion>? 2-1"22-1*
Figure 122: ;lobal 5iosimilars Market b' )egment <@>? 2-1*
Figure 12": ;lobal 5iosimilars Clinical Pipeline b' Phase <@>? 2-1
Figure 12: ;lobal 5iosimilars Clinical Pipeline b' Phase <4umber>? 2-1
Figure 12%: 4o Development 1eported in 5iosimilars Clinical Pipeline b'
Phase <@>? 2-1
Figure 12&: 4o Development 1eported in 5iosimilars Clinical Pipeline b'
Phase <4umber>? 2-1
Figure 12(: Discontinued 5iosimilars in Clinical Pipeline b' Phase <@>? 2-1
Figure 12*: Discontinued 5iosimilars in Clinical Pipeline b' Phase <4umber>?
2-1
Figure (21: 5iocon 5iosimilars Pipeline
Figure (22: 7arvest Moon Pharmaceuticals 5iosimilars Pipeline
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