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1 Biosimilars - the second wave Dr. Frank Wartenberg, President Central Europe © 2017, QuintilesIMS (IMS HEALTH GmbH & Co. OHG). All rights reserved.

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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

E: [email protected]

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)