Praesentation biosimilars-2020-frank-wartenberg-quintiles ims-092017
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Transcript of Praesentation biosimilars-2020-frank-wartenberg-quintiles ims-092017
1
Biosimilars - the second wave
Dr. Frank Wartenberg, President Central Europe
© 2017, QuintilesIMS (IMS HEALTH GmbH & Co. OHG). All rights reserved.
2© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
Era analysis
1st wave of
Biosimilars
(small
molecules)
2nd wave of
Biosimilars
entering the
market
Innovative
wave of
Biologics on
the horizon
3
Die Biologika dominieren das Gesamtwachstum im
Markt - Autoimmun und Onkologie als Topindikation
© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
Biologika Sales und Trends Deutschland (2011-16)
Milliarden Euro
0%
5%
10%
15%
12
10
4
2
0
14
6
8
10
2012
9
2011 2016
13
2015
8
11
2014
11
2013
Gesamtmarktwachstum
Biologika Wachstum
Biologika Sales
Quelle: QuintilesIMS MIDAS MAT Q1 2017
Andere34%
Okuläre Antineo-
Vaskularisation
21%
Onkologika
22%
4%
Vakzine
9%
Anti-Diabetes
10%
Autoimmun
Top 5 Biologika Therapiegebiete,
Umsatz Deutschland (2016)
4© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
Die Biologika haben den Hauptanteil an den Top 10
Produkten
24%
68% 67%
2013
3.8
3.515%
2012
32%
2015
33%
4.8
2014
28%
4.3
76%
2016
4.6
72%85%
Andere
Biologika
Anzahl der
Biologika:7 8 7 7 6
Xarelto
Harvoni
Revlimid
Eliquis
Humira
Avastin
Enbrel
Mabthera
Herceptin
Lucentis
Umsatzanteil der Biologika an den Top 10 Produkten
Deutschland, Milliarden. Euro, 2012-2016
Quelle: QuintilesIMS MIDAS Q1 2017, Rx only
5© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
Die Hersteller eröffnen neue Märkte, indem sie Biologika
für traditionell niedermolekulare Produkte erforschen
6
10
11
12
12
12
12
13
17
23
27
30
32
34
45
Osteoporosis
Osteoarthritis
Heart failure
Ebola
Pain
Allergy
Parkinson’s
Dengue fever
COPD
Stroke
Uveitis
Malaria
HIV
Asthma
Alzheimer’s
Common Factors
• Dominated by small
molecules and highly
genericised
• High patient population
• Aim to treat severe
subsections of these
indications
• Mixed experience to date
with pioneer biologics
taking this route (Xolair in
respiratory, Praluent in
hyperlipidemia)
Biologika Pipeline: Neue Biologika Indikationen
Pre-Clin to Reg
Quelle: QuintilesIMS R&D Focus April 2017; Thought Leadership analysis
6
Biologic sales (Bn)EU Patent
expiry date
2018
Expired
Expired
2019
Expired
Expired
Expired
2021
2022
Expired
1.3
0.5
Mabthera (rituximab)
Herceptin (trastuzumab)
1.0 Remicade (infliximab)
0.4
Enbrel (etanercept)
0.51.4
0.5
Avastin (bevacizumab)
1.4 0.6
Humira (adalimumab)2.6 1.1
0.61.3
Lantus (insulin glargine)0.9 0.4
Lucentis (ranibizumab)1.1 0.2
Eylea (aflibercept)1.0 0.3
Lovenox (enoxaparin Sodium)1.0
© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
Die wichtigen Biologika haben entweder schon ihr
Patent verloren oder stehen kurz davor
Abasaglar, Toujeo
Inflectra, Remsima, Flixabi
Rest of EuropeEU5
Benepali
Truxima
Biosimilars
Europa Top 10 Biologika Sales nach MolekülLCUS$ 2016
Quelle: QuintilesIMS MIDAS Q4 2016
7© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
Die Pipeline für Substanzen, bei denen in naher Zukunft
das Patent ausläuft, ist gut gefüllt
3 2 1
Late clinical phase8 6 11 9
9 9 3 6
8 19 12 7
Approved (*on market)
Early clinical phase
Pre-Reg./Reg.
Rixathon* Solymbic
Truxima* Amgevita
Rituximab
Patent exp. 2017
Trastuzumab
Patent exp. 2017
Adalimumab
Patent exp. 2018
Bevacizumab
Patent exp. 2019
Europäische Biosimilar Pipeline von ausgewählten MolekülenPreclin. to Approved
Quelle: QuintilesIMS; August 2017; Analysis developed by QuintilesIMS Biosimilars Center of Excellence using public sources of information,
including company websites
8© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
In der Vergangenheit war der Biosimilarmarkt nicht sehr
kompetitiv – dies ist gerade im Umbruch
Autoimmune20%
Oncologics20%
Antidiabetics9%
Erythropoietins4%
Hematopoietic Growth Factors
2%
Growth Hormones2%
• Rituximab
• Trastuzumab
• Etanercept
• Infliximab
• Insulin glargine
Europa Top Biologika Therapiegebiete LCUS$ 2016
Quelle: QuintilesIMS MIDAS MAT Q3 2016; Europe excludes Russia and Turkey
9
Neuste Entwicklungen zeigen, dass es immer mehr
Optionen für Biosimilars gibt die Biologika zu ersetzenIndustry News
© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
Market Access of
new Biosimilars
Public institutions
promote Biosimilar
usage
Biosimilar equivalent to
Biologic
Academia supports
Biosimilar usage
• JAMA Editors endorse
trastuzumab biosimilar in light
of Phase 3 data publication
• Major European study on real-
world experience with oncology
biosimilars welcomed in US
• South Korea becomes first
highly regulated market to
approve rituximab biosimilar
• EMA poised to approve first
biosimilars of teriparatide
• NOR-SWITCH study and Triple
switch study show equivalence
between biosimilar and biologic
• Pfizer’s trastuzumab biosimilar,
Sandoz’s rituximab biosimilar &
Momenta’s adalimumab
biosimilar for psoriasis show
equivalence to biologic
• EMA to pilot tailored advice on
step-by-step development of
new biosimilars
• ECCO endorses switching to
biosimilar infliximab in
inflammatory bowel disease
10
Die Hauptwachstumstreiber Autoimmun und Onkologie
sind wichtige Entwicklungsgebiete für Biosimilars
Global Biosimilar Pipeline by phase
July 2017
© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
154
17
75
43
141
Ap
pro
ve
d
Pre
-re
g.
Ph
ase
III
Ph
ase
II
Phase I
Pre
-clin
ica
l
92 biosimilars in late
stage development
36
9
13
34
50
50
54
Others
Bone Disorders
Immunostimulant
Endocrine Disorders
Autoimmune
Oncologics
Blood and
Lymphatic Disorders
Global Biosimilar Pipeline by therapy area
Phase III to Approved
Quelle: QuintilesIMS; July 2017; Analysis developed by QuintilesIMS Biosimilars Center of Excellence using public sources of information, including
company websites
11
4
4
4
4
4
4
5
5
5
5
5
6
6
7
7
7
9
11
14
Intas Biopharm.
Reliance Life Sciences
NanoGen
Dong-A Pharm.
Dr. Reddy’s Lab.
Biosidus S.A.
Wockhardt
Amega Biotech
Zydus Cadila
Sandoz
AryoGen Pharmed
Lupin
Amgen
Shanghai CP
Pfizer
Biocon
LG Life Sciences
128Others
Biocad
Samsung Bioepis
Aug 21th, 2017
Samsung Bioepis & Takeda
partner to Develop Novel
Biologic Therapies
• Signed strategic collaboration
agreement to co-develop multiple
innovative biologic therapies in unmet
disease areas, expanding the Korean
company's current focus beyond
biosimilars
• Immediate program focus on TAK-
671, a therapeutic candidate intended
to address unmet need in severe
acute pancreatitis
Biosimilars bieten den Eintrittspunkt für einige
Hersteller in diesen innovativen Markt
© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
Globale Biosimilar Pipeline nach Hersteller
Phase III to Approved
Originators
Quelle: QuintilesIMS; July 2017; Analysis developed by QuintilesIMS Biosimilars Center of Excellence using public sources of information, including
company websites
12
Infliximab- und Rituximab-Biosimilars konnten den
schnellsten Markteintritt im ersten Quartal erzielen
© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
EU5
Quelle: QuintilesIMS AMVXL 09/2017; Uptake in Euro normalized to launch
25%
5%
0%
20%
10%
15%
M1M0 M12M11M10M9M8M7M6M5M4M3M2
ETANERCEPT (LoE 03/16)
RITUXIMAB (LoE 04/17)
INSULIN GLARGINE (LoE 09/15)
INFLIXIMAB (LoE 02/15)
Biosimilar uptake Germany
Share of molecule sales in Euro, normalized to launch
13
Die Biosimilar-Penetration ist in Europa ohne
einheitliches MusterE
U5
Hig
h p
en
etr
atio
n E
U
High
uptake
Low
uptake
Biosimilar share of molecule treatment days
06/2017, Europe, Japan, Canada
© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
Country InfliximabInsulin
glargineEtanercept Rituximab
UK 77.7% 3.7% 53.3% 7.6%
France 31.4% 3.8% 4.3% -
Germany 44.0% 6.5% 35.2% 8.5%
Italy 55.3% 14.9% 10.3% -
Spain 42.3% 7.6% 2.9% -
Finland 93.1% 3.3% - -
Norway 97.7% 3.2% 80.9% -
Poland 100.0% 23.4% 16.5% -
Denmark 97.4% 5.1% 76.9% -
Quelle: QuintilesIMS MIDAS MTH June 2017
14© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)
Was sagt die Glaskugel über die Zukunft der
Biosimilars?
• In the absence of any other
differentiators biosimilar
selection is driven by price –
if they are taking the route of
small molecule generics then
a long term sustainable
market would be at risk
• Increasing competition and
the dynamics of multi-
sourced products will allow
payers stronger negotiating
options
• Savings and patient
access will drive
acceptance of next
wave of biosimilars
• Positive studies
and experience will
drive broad
adoption of
biosimilars by
physicians
• Regulatory
developments
generally favour
biosimilars but
‘naming’ and
‘patent information
exchange/linkage’
remain challenges
• Adoption of substitution
rules may parallel use of
generic medicines
• Procurement methods will
speed up uptake and
increase price differentials
• Awareness and usage of
biosimilars across varying
therapeutic areas will
accelerate biosimilar usage
Policy Price
Acceptance Usage
15
Vielen Dank
Dr. Frank Wartenberg
President Central Europe
T: +49 69/6604-4315
@FrankWartenberg
16
© 2017, QuintilesIMS (IMS HEALTH GmbH & Co. OHG)
All rights reserved. This information may not be reproduced, stored, processed, or made accessible in any way in whole or in part, without the prior
express permission of QuintilesIMS (IMS HEALTH GmbH & Co. OHG).
The terms "patient," "physician," "physician's office," "prescriber," or "pharmacy" possibly used in this document in connection with data do not refer
to personal information but exclusively (pursuant to § 3 (6) Federal Data Protection Act) to anonymous information.
Through the use of state-of-the-art technologies and processes, IMS ensures that its services comply with data protection regulations, regardless of
how the data are linked to each other
© 2017, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg)