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Biosimilars in the European Market – why and how - EGA Events

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07/04/2014
Biological/biotechnological and biosimilars
market: the global outlook with special
focus on Europe
Biosimilar Medicines: 12th EGA International Symposium
London, April 3rd 2014
Agenda
• The Global Biologic Market
в€’ The increasing importance of biosimilars in the pharma portfolios
в€’ Recombinants shaping the industry
• The Macro Biosimilars Environment
в€’ NOB Players in emerging markets
в€’ The biosimilar pipeline a focus on RA
• Policy Implications
• The trade-off between access and innovation
2
1
07/04/2014
Biologics growth continues to outstrip growth rate of
total pharma
Such a trend is putting additional financial pressure on
healthcare budgets
Biologics – Share of sales
Global market trends
Sales and Growth
8.4%
200
12%
7.9%
49.7%
180
10%
140
8%
120
100
6%
80
4%
60
40
12.6%
Growth, LCUS$
Sales, US$ billions
160
21.4%
Japan
Pharmerging
13.1%
59.4%
0%
2008
2009
2010
2011
Biologics Sales
2012
US
5.3%
2%
2007
EU5
Biologics – Share of growth
20
-
ROW
2013
10.0%
Biologics Growth
12.3%
Total Pharma growth
Source: IMS Health, MIDAS, MAT June 2013
3
В© 2013, IMS HEALTH
Key therapies in today’s world
LoEs have reset the stage from small molecules to biologics
Europe Top 10 products 2008-13
2008
2009
2010
2011
2012
2013
1
LIPITOR
LIPITOR
LIPITOR
SERETIDE
HUMIRA
HUMIRA
2
SERETIDE
SERETIDE
SERETIDE
LIPITOR
SERETIDE
SERETIDE
3
PLAVIX
PLAVIX
HUMIRA
HUMIRA
HERCEPTIN
ENBREL
4
HERCEPTIN
ENBREL
ENBREL
ENBREL
ENBREL
HERCEPTIN
5
ENBREL
HERCEPTIN
HERCEPTIN
HERCEPTIN
LIPITOR
MABTHERA
6
ZYPREXA
HUMIRA
LOVENOX
LOVENOX
MABTHERA
REMICADE
7
LOVENOX
LOVENOX
AVASTIN
MABTHERA
LOVENOX
LOVENOX
8
GLIVEC
GLIVEC
MABTHERA
AVASTIN
REMICADE
AVASTIN
9
PANTOZOL
ZYPREXA
GLIVEC
REMICADE
AVASTIN
LUCENTIS
10
SYMBICORT
MABTHERA
ZYPREXA
GLIVEC
SPIRIVA
LYRICA
Small molecule products
Biologic products
Source: IMS Health, MIDAS, MAT June 2013
4
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07/04/2014
It’s the loss of exclusivity that drives interest.
12 compounds represent US$ 73 billion in sales
All these products will lose patent protection by 2020, except Enbrel (US patent extended
until 2028)
Global Sales (MAT 09/2013), US$ billion
9.4
7.8
7.5
7.5
5.6
5.6
2016
Etanercept (Enbrel)
2015
2028 (extended)
Infliximab (Remicade)
2015
2018
2014
2015
Rituximab (Mabthera)
Expired
2018
Bevacizumab (Avastin)
2019
2019
Expired
Expired
2015
2016
2014
2019
2017
2014
2015
2015
2016
2016
Insulin Aspart (Novomix, Novorapid)
5.4
Interferon Beta-1A (Avonex, Rebif)
5.1
Total
~ US$ 73
billion
4.8
4.3
4.3
Trastuzumab (Herceptin)
Glatiramer Acetate (Copaxone)
Pegfilgrastim (Neulasta)
Ranibizumab (Lucentis)
5
US expiry date
2018
Insulin Glargine (Lantus)
6.2
0
EU expiry date
Adalimumab (Humira)
10
Not considered existing biosimilars
such as Epoetin Alfa expired in EU, but
still patent protected in the US
Source: IMS MIDAS, 09/2013, IMS Patent focus
5
Agenda
• The Global Biologic Market
в€’ The increasing importance of biosimilars in the pharma portfolios
в€’ Recombinants shaping the industry
• The Macro Biosimilars Environment
в€’ NOB Players in emerging markets
в€’ The biosimilar pipeline a focus on RA
• Policy Implications
• The trade-off between access and innovation
6
3
07/04/2014
In Europe, biosimilar usage exhibits different rates
with Italy and Spain now catching up
$US Millions
Biosimilar sales across EU5
QTR 03/2007 – 12/2013 ($US)
EU 5 countries
490M $
MAT 12/2013
40
Fast uptake at launch
35
Consistent uptake
30
Cultural resistance at first but change
undergoing
25
20
15
10
5
0
Mar-07 Sep-07 Mar-08 Sep-08 Mar-09 Sep-09 Mar-10 Sep-10 Mar-11 Sep-11 Mar-12 Sep-12 Mar-13 Sep-13
France
Germany
Italy
Spain
UK
Source: IMS MIDAS, MAT Dec 2013
7
Filgrastim excels in each major EU market
Almost resembles small molecule generic efficiency in some
countries
Biosimilar uptake across TA/Countries
MAT 12/2013 (Volumes, SU)
Values, M$
130
104
102
86
56
SPA
UK
% Uptake, SU
80%
70%
60%
50%
40%
30%
20%
10%
0%
ITA
GER
ALL
Filgrastim
FRA
Somatropin
Ep. Alfa
Source: IMS MIDAS, MAT 12/2013
8
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07/04/2014
Dynamics differ not only by molecule and country
but also by channel
Biosimilars and originals breakdown (molecule vs. molecule only; and only reference products)
Mar-13
Mar-12
Sep-12
Mar-11
Sep-11
Mar-10
Sep-10
Mar-09
Sep-09
Mar-08
Sep-08
Mar-07
Sep-07
Mar-06
Sep-06
Mar-13
Mar-12
Sep-12
Mar-11
Sep-11
Mar-10
Sep-10
Mar-09
Sep-09
Mar-08
Sep-08
Mar-07
Sep-07
Mar-06
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Sep-06
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
BIOSIMILAR PRODUCTS (R)
ORIGINAL (H)
Mar-13
Mar-12
Sep-12
Sep-11
Mar-11
Sep-10
Mar-10
Sep-09
Mar-09
Mar-08
Sep-08
Sep-07
Mar-07
Mar-06
Mar-13
Mar-12
Sep-12
Sep-11
Mar-11
Mar-10
Sep-10
Mar-09
Sep-09
Mar-08
Sep-08
Mar-07
Sep-07
Mar-06
Sep-06
ORIGINAL (R)
Sep-06
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
BIOSIMILAR PRODUCTS (H)
Source: IMS MIDAS Q2 2013. Analysis in DDD (Defined Daily Doses).
9
The temperature is rising again, biosimilar events
are warming the global agenda
ROW
Market trends
Regulatory
2012
Remsima
(Infliximab
Biosimilar)
launched in Korea
FDA approved
Tbo-filgrastim
but filed in the
U.S. as BLA
2nd GSF approved
in Japan
2013
Sandoz
Omnitrope to be
sole subsidised
somatropin from
Jan 2015 in NZ
Teva announce
launch of
GRANIX in USA
Herzuma
(Trastuzumab bs)
approved in
Korea
Jun
Mar
Jul
Nov 2014
Europe
Italy, largest
Biosimilars
market in EU*
Market trends
Regulatory
NВ° of Biosimilar
applications
(EMA) all-time
high (8)
Biosimilar G-CSF
(Zarzio)
prescribed more
than originator
Inflectra#
(Infliximab
Biosimilar)
approved EU
Lilly & BI
submission for
insulin glargine
biosimilar
Follitropin alfa
biosimilar
approved
Source: Secondary research. List not exhaustive. (*) at ex-manufacturer price levels, not including rebates and discounts.
(#) Recommended for RA (Rheumatoid arthritis), CD (Crohn’s disease), UC (Ulcerative colitis),
AS (Ankylosing spondylitis), PA (Psoriasis), PsA (Psoriatic arthritis)
5
07/04/2014
Relaxed regulatory requirements drives proliferation
of Non Original Biologics in emerging markets
Biologics
Non Originals
Originals
True
Innovator
Type
• Efficacy/safety
improvements
• Disruptive
Description technologies, big
advances in
efficacy
• Less stringent
comparability
• Affordable, high
quality
• Same target but
• New drug against differentiated
new target
(e.g. Better
efficacy, safety,
administration)
Target
Non Original
Biologics
Biosimilars
Bio-betters
• Drug aiming at
copy innovator
• Clinical
equivalence and
comparability to
originators
• Focus on patient
access, EMs
Example
11
В© 2013, IMS HEALTH
Major opportunity exists in BRICs where NOBs
account for 91% of the 16 markets
Biologic size, $US Mn
Retail only
0
1В°
CN
2В°
BR
3В°
RU
4В°
TR
5В°
MX
6В°
IN
7В°
TH
352
8В°
ID
177
9В°
VN
119
1В°
AL
238
2В°
AR
232
3В°
SA
165
4В°
EG
104
5В°
PK
96
6В°
VZ
62
7В°
CO
14
Recombinant NOBs uptake
16 Pharmerging markets
NOBs
2.000 4.000 6.000
60%
40%
20%
37%
4.162
CN
2В°
BR
10В°
RU
4В°
1%
TR
14В°
2%
MX
13В°
IN
3В°
TH
6В°
ID
7В°
VT
1В°
AL
15В°
AR
9В°
SA
16В°
EG
8В°
PK
5В°
2%
VZ
12В°
3%
CO
11В°
6%
3.923
23%
2.544
1.305
Russia
1.000
534
338
Turkey
Pakistan
Algeria
Thai
Egypt India
Mexico
VN
China
44
Brazil
82
18%
41%
0%
30
Indo
130
30%
13%
927
6%
Vietnam
0%
9%
Argentina
22%
Bubble size: NOBs 2012 $US Mn
Rk
0%
Retail only
Rk
BRICs countries account for 91% in value of the NOBs Pharmerging market.
Three of them also come on top with regards to NOBs penetration
Source: IMS MIDAS Dec 2012. Data is retail only for Algeria, Argentina, Colombia, Egypt, Pakistan, Saudi Arabia, Venezuela.
(*) Size of NOBs could be underestimated in Mexico and Brazil due to panel coverage.
12
Uptake is based on recombinant and synthesised molecules.
В© 2013, IMS HEALTH
6
07/04/2014
NOBs have made significant impact in major biologic
therapy areas
Oncology
Anti-TNF
• Reditux was the world’s first
non originator mAbs
• Launched in 2006, one year
before Enbrel, Yi Sai Pu had
the highest anti-TNF sales in
China, with ~$41m in 2012
• In 2007, it was priced at
$243 for a 100 mg dose in a
10 ml vial, about 50% lower
than the price of originator
Mabthera (Roche)*
• China has one the lowest
RA prevalence in the world
(undiagnosed contribute). As
its population continues to
grow, monitoring RA cases
and biologic’s use important
• Between 2007 and 2012,
Reditux achieved in India
81% CAGR, it is now the 2nd
largest oncology product in
India (not considering Roche)
• Yisaipu is also the least
expensive among Anti-TNF
Interferons
• Launched end 2010 by
Laboratorio Tutuer (AR)
• Genfaxon won back market
share from direct competitors
(Rebif and Avonex) in tenders
for Multiple sclerosis products
within 7 Nosologies
program (high cost part of
DLO)
• Genfaxon is now the 5th
biologic product in Russia
(PPG 90%)
Source: IMS Health, MIDAS, MAT Dec 2012. AR: Argentina (*) Bloomberg
13
В© 2013, IMS HEALTH
The global playing field continues to expand with
players finding niches
Players differ not only in geographical spread but also a wider
biologic portfolio
# Pharmerging markets only
International
Reach
Government
backed players
Emerging
markets
players
Serving 2+ countries
Domestic
players
Serving domestic market only*
Source: IMS Health, MIDAS, MAT Dec 2012. (*) restricted to MIDAS sales data and recombinant and synthesised prods only.
14
В© 2013, IMS HEALTH
7
07/04/2014
RA biosimilar development is a hive of activity
Preclinical
rituximab for unknown
indication
infliximab
Avetux (Avesthagen)
BioXpress
Amgen/Watson
Richter/Stada
Harvest Moon
AP052 (Aprogen)
Coherus/Daiichi Sankyo –
Early phase
GS071 (Aprogen)
Harvest Moon
Tocilizumab
rituximab for NHL
BOW 015 (Epirus)
Phase 3
Harvest Moon
MabionCD20 (Mabion)
CT-P10 (Celltrion)
Golimumab
Inflectra (Celltrion/Hospira)
GP2013(Sandoz)
rituximab for RA
CT-P10 (Celltrion)
Filed in
EU/approved
Harvest Moon
TL011 (Teva)
MabionCD20 (Mabion)
MK-8808 (Merck)
GP2013(Sandoz)
PF-05280586 (Pfizer)
SAIT101 (Samsung/Quintiles)
BioXpress
LBEC0101 (LG Life Sciences)
TuNEX
etanercept
Certolizumab
Harvest Moon
BI-695501 (BI)
Avent (Avesthagen)
Biocon/Mylan
Adalimumab
Harvest Moon
Coherus/Daiichi Sankyo
BioXpress
Biocon/Mylan
BioXpress
PRX-106 (Protalix)
Source: IMS consolidation from public data
Harvest Moon
The list is not exhaustive
Trials may have moved forward or being discontinued
15
Amgen/Watson
Harvest Moon
BioXpress
Abatacept
В© 2013, IMS HEALTH
Could we soon see the introduction of biosimilars
shortly after patent expiry in this area?
Each LOE could be closely followed by a biosimilar entry
Inflectra (Remicade –Celltrion*)
Rheumatoid Arthritis
market
GP 2013 (Rituximab - Sandoz)
GP2017 (Adalimumab - Sandoz)
New European market
Entrants (estimate)
2013
Patent Expiries in EU5
(France, Germany , Italy,
Spain & UK)
2014
2015
2016
2017
Remicade
Rituxan
Enbrel
2018+
Humira
Cimzia
Orencia
Simponi
RoActemra
* Approved Sep 2013
Source: IMS Knowledge Link, PADDS
Products in Phase 2 or 3 may not receive approval; pipeline view does not
necessarily align with the projected competitive landscape in a given year
16
8
07/04/2014
Anti-TNF and MAbs are the key RA biologics
Surveyed physicians estimate only around half of RA patients
are currently still receiving their first line therapy
Mild
Moderate
Severe
NSAIDs
35.1%
35.0%
36.8%
Cox-2 inhibitors
17.2%
16.7%
17.5%
Traditional DMARDs
64.4%
67.7%
66.9%
Biologic TNF inhibitors
8.6%
28.5%
40.7%
Biologic non-TNFs
3.9%
12.2%
19.9%
Novel small molecules
2.1%
3.9%
5.8%
19.3%
18.8%
19.0%
Traditional Chinese medicine
Traditional Herbal Medicine
Corticosteroids
3.8%
1.5%
1.5%
15.8%
22.3%
37.8%
First-line
Second-line
Third-line
Fourth-line
Fifth-line
Sixth-line or more
IMS primary market research, 2013(n=210), Countries included: China, Spain, Italy, France, UK, Brazil, Germany, Japan, USA
Source: IMS Health Disease Insight
17
Thus a high rate of treatment switching exists in RA
After 2 years, physicians estimate ~50% of RA patients switch
to another therapy...an opportunity for biosimilars?
Percent of RA patients switching from brand (%)
50
45
3 months
6 months
2 years
40
35
30
25
20
15
10
5
0
Methotrexate
Enbrel
Remicade
Humira
Rituxan/MabThera
IMS primary market research, 2013(n=210), Countries included: China, Spain, Italy, France, UK, Brazil, Germany, Japan, USA
Source: IMS Health Disease Insight
18
9
07/04/2014
One key understanding should be the role of
medicines within overall cost of treatment
Cost
RA treatment cost
distribution, 2008
25000
20000
15000
10000
5000
0
The per-patient cost of RA biologic treatment is high, with biologics
representing ~22% of direct medical costs
* Source: Access To Innovative Treatments in Rheumatoid Arthritis In Europe, 2009
19
New biologic launches continue and represent an
ongoing challenge for upcoming biosimilars
Superior clinical results will gain clinician and patient attention
whilst associated costs will prove problematic for payers
Originators
Biosimilars
adalimumab
cetuximab
New modern
insulins
Gazyva
infliximab
interferon
beta
etanercept
New biologics
rituximab
Perjeta
(pertuzumab)
bevacizumab
Lonquex
(lipegfilgrastim)
trastuzumab
insulins
20
Kadcyla
(trastuzumab
/drug
conjugate)
SC Herceptin
and Rituxan
В© 2013, IMS HEALTH
10
07/04/2014
Agenda
• The Global Biologic Market
в€’ The increasing importance of biosimilars in the pharma portfolios
в€’ Recombinants shaping the industry
• The Macro Biosimilars Environment
в€’ NOB Players in emerging markets
в€’ The biosimilar pipeline, a focus on RA
• Policy Implications
• The trade-off between access and innovation
21
Payers and policy-makers rise as biosimilar
advocates
Biosimilar strategies & business model will shape future scenarios
Stakeholder drivers
Payer /
Government
Physician
Patient
Aspiring
player
Originator
Impact on biosimilars market
• Healthcare rationalization
• Ensure safety and clinical efficacy
• Leverage macroeconomic growth through
biosimilars
Strong
barrier
Neutral
• Safety and clinical efficacy concerns
• Need to build learning curve on
biosimilars
• Reaction to differ by therapy area
• Looking for broader and affordable access
• Likely to be influenced by physician
advice
• Massive capital invested on biosimilars
• Branded players bringing in R&D
capabilities
• Growing specialization along the value
chain (CRAMS providers)
• Lifecycle management
• Patent disputes
• Active players in the biosimilar arena
EU, 2013
22
Strong
driver
EU, 2018
В© 2013, IMS HEALTH
11
07/04/2014
The Biosimilar market of mature countries
faces a paradox
The largest
biologic market
potential and cost
burden
Low overall
current impact of
biosimilars
Next wave of
biosimilars will be
challenging
There are several
indications that
the status quo is
about to change
•
The US and European biologic markets
comprise the majority of value size and
growth, we expect this to continue
•
As such, the majority of biologic cost burden
falls on these markets –and potentially the
most attractive non originals opportunity
•
Despite 7 years of biosimilars in the EU, and
recent FDA guidelines, biosimilars comprise
a very small % of the mature markets
•
Significant impact in certain TAs and
countries, low overall
•
MAbs for oncology and autoimmune pose
incremental acceptance and uptake
challenges
•
Originators seek to move standard of care
on bio-betters
•
We are entering an era with great potential
for change in the biosimilars market...
•
Marked by the LoE of complex compounds
used in large populations and foreshadowed
by a number of "firsts" in what is being
brought to market, by whom, and where.
Will payers push
for greater BS
adoption as costs
escalate?
What adoption do
we expect for the
next wave of BS?
To what extent is BS
experience an
indicator of future
dynamics?
To what extent is
competition
intensifying?
23
В© 2013, IMS HEALTH
The potential exists for a reverse innovation business
model producing a threat to R&D in the West
Biopharmaceutical industry
Globalization
Step
1
Step
2
Biologics R&D in
mature markets
and made in
mature markets
for EMs
Biologics R&D in
mature markets
but made in EMs
for EMs
пѓј Classic biologics R&D
in mature markets
Reverse Innovation
Step
3
Biologics R&D in
EMs and made in
EMs for EMs
пѓј Emcure/Roche deal to пѓј Molecules marketed
manufacture antiin EM but not in
cancer drugs in India
Western markets
for India
(e.g. Ninotuzumab)
пѓј MedImmune JV with
WuXi to develop
novel biologics for
China
Step
4
Biologics R&D in
EMs and made in
EMs for the world
 Celltrion’s bioinnovative pipeline
CT-P19 (rabies
virus)
пѓј Celltrion developing
an armed antibody?
Threat to major
Western Biopharma
Source: Model readapted from Vijay Govindarajan. The Economic Times. Nomura.
24
12
07/04/2014
IMS Health
Thank You
Alan Sheppard,
[email protected]
Stefano Di Biase, [email protected]
Disclaimer
The analyses, their interpretation, and related information contained herein are made and provided
subject to the assumptions, methodologies, caveats, and variables described in this report and are based
on third party sources and data reasonably believed to be reliable. No warranty is made as to the
completeness or accuracy of such third party sources or data.
As with any attempt to estimate future events, the forecasts, projections, conclusions, and other
information included herein are subject to certain risks and uncertainties, and are not to be considered
guarantees of any particular outcome.
All reproduction rights, quotations, broadcasting, publications reserved. No part of this presentation may
be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy,
recording, or any information storage and retrieval system, without express written consent of IMS
HEALTH.
В©2014 IMS Health Incorporated and its affiliates. All rights reserved. Trademarks are registered in the
United States and in various other countries.
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