Biologics Market: An Overview

Developments, Trends and Strategies

ANDREW BOURGOIN
Andrew.Bourgoin@thomsonreuters.com
NY Pharma Forum
January 31st, 2012

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2

Agenda

Competition in Follow-on Biologic Development

Incentive and Challenges to Compete
Established Companies
Global Development

Strategies, Trends and Forecasts

Gaining a Competitive Advantage through M&A

Takeaways and Questions

2011 Thomson Reuters.

Competitive
Landscape

Biologics: a $90bn Global Market

Class

#Launched

WW Sales
US$

No.
Blockbusters

%Blockbuster
Sales

rhProtein

65

$52bn

13

80%

MAb

26

$42bn

90%

Total

91

$94bn

22

85%

5
Source: IMS Health, Newport Premium for Generics, TR Research

Incentive To Compete In The Follow-on Biologic Market

7
6
5
$B 4
3
2
1

US
WW

6
Source: IMS Health, Newport Premium for Generics, TR Research

Global MAbs Market

INN
Infliximab
Adalimumab
Bevacizumab
Rituximab
Trastuzumab
Ranibizumab
Cetuximab
Palivizumab
Natalizumab
Omalizumab
Panitumumab
Eculizumab

WW Sales
(US$B)
6.3
6.6
5.4
5.3
4.4
3.4
1.5
1.4
9
8
4
2

Biosimilar Competition Not Expected Before

Growth
10%
19%
1%
9%
10%
32%
5%
10%
16%
16%
81%
26%

USA
2010
2010
2011
2016
2008
2017
2015
2015
2014
2007
2017
2014

EU
2014
2018
2014
2013
2014
2014
2014
2014
2014
2014
2017

JPN
2012
2018
2016
2016
2014
2019
2016
2015
2017
2018
2020

7
Source: IMS Health via Newport Premium for Generics, TR Research

First Wave FOB Launches

Therapy

Brand Name

Company

Markets

Somatropin

Omnitrope

Sandoz

EU, USA,
Canada, Japan

EPO

Epokine

CJ Corporation

South Korea,
Thailand

EPO

Binocrit

Sandoz

EU

EPO

Retacrit

Hospira

EU

EPO

Wepox, Epox

Wockhardt

India

EPO

Epiao

3SBio

China

EPO

Erypo

Biocon

India

Filgrastim

Nivestim

Hospira

EU, Austrailia

Filgrastim

Ratiograstim

Ratiopharm

EU

INF A 2a

Intefen

3SBio

China

INF A 2b

Realdiron

Biotechna

Ukraine
8

Major Generic Companies Active in FOB Development

Company

Proteins

Antibodies

Vaccines

Teva

FP

UD

Sandoz

FP

UD

Biocon

FP

UD

Hospira

FP

UD

EPO, HGH

Zydus

FP

UD

GCSF

STADA

FP

UD

EPO

Actavis

FP

Ranbaxy

FP

UD

Dr Reddys

FP

FP

Apotex

FP

UD

Cipla

FP

Launches

EPO, GCSF
EPO, HGH

FP

GCSF

Via Bioton
FP
GCSF
FP

UD
Key: FP = Full Production, UD = Under Development
Source: TR Research

Big Pharma Committed To Compete

Many of the traditional innovator companies have the
most to lose from competition in the follow-on biologics
market. Conversely, companies with established sales
and marketing forces in the US will have a competitive
advantage against competition void of such attributes.
-Thomson Reuters White Paper
Company

Strategic Positioning (year)

Pfizer

Announcement (10), Biocon

Merck

Bioventures (09), Parexel, Hanwha (11)

Amgen

Watson (11)

Biogen Idec

Samsung (11)

Baxter

Momenta (11)

Boehringer Ingelheim

Announcement (11)
10

Biosimilars and the Patient Protection and Affordable

Care Act (H.R. 3590)

Section 351 of the Public Health Service Act (PHSA) amended

to include an abbreviated biological license application (aBLA)
for highly similar biological products
Safety and efficacy
Large-scale clinical studies
Same condition(s)s of use, route(s) of administration, dose
form, strength and utilizes the same mechanism(s) of action
as reference product
Interchangeability
Must produce the same clinical results as the reference
product

Exclusivity
Continuing debate
11

Biosimilars and the Patient Protection and Affordable

Care Act (H.R. 3590) Continued

Biosimilar User Fees

Congressional Consideration
Many Similarities to the PDUFA Fee structure
Performance Goals

Pre-Market Phase
Initial or annual biosimilar product development fee (BPD)
Reactivation Fee
Marketing Application Fee

Post-Market Phase
Establishment fee
Product Fee

Initial Guidance?

Which Route to take?

Waiting game
NEMJ article

351(a) v. 351(k)

12

Barriers To Entry Will Limit Competition

Biomanufacturing facility, additional capabilities

Significant clinical and non-clinical testing
Substantial, NDA-type dossiers
Post-market safety surveillance
Substantial manufacturing investments
Sales promotion and marketing
Intellectual property considerations

13

Recombinant Protein Production: Emerging Markets

20

Number of Companies

18
16
14
12
Under Development

10

Full Production

8
6
4
2
0
India

China

ROW

14

MAb Production: Emerging Markets

18

Number of Companies

16
14
12

10
Under Development
8

Full Production

6
4
2
0
India

China

ROW

15

Companies Currently Manufacturing or Developing

Active Substances For FOBs

35

30

25

20

Inexperienced
Experienced

15

10

China

India

ROW

EU
16

Biotech Capabilities Among The Top Chinese

Company

Proteins

Antibodies

Vaccines

Launches

Anhui Anke

FP

HGH, IFN

Amoytop

FP

GCSF, IFN, HGH

Beijing SL

FP

GCSF

Beijing Tiantan

FP

Citic Pacific

FP

Chanchung Institute

FP

Chengdu Hoist

UD

Hep B
Etanercept

FP
FP

GCSF, IFN
Radio MAb

Dalian Hissen

FP

Hep B, Rabies

National Serum

FP

Various

Shenzen Kexing

FP

IFN, HGH

Shenyang Sunshine

FP

EPO, IFN, IL2

Wuhan Institute

FP

FP

MAb

Key: FP = Full Production, UD = Under Development

Source: TR Research

17

Biologic Development in Japan and S Korea

Company

Proteins

Aska

UD

Celltrion

FP

CJ Cheil Jedang

FP

Dong-A Pharmaceuticals

FP

Fuji

UD

Antibodies
UD

ISU ABXIS

UD

LG Life Sciences

FP

Mochida

UD

Nippon Kayaku

UD

Samsung

EPO
EPO, GCSF, INF,
HGH

UD

FP

Launches
Abatacept

FP

Gene Techno Science

Kissei

Vaccines

FAb

GCSF
FP

EPO

UD

18

2011 Thomson Reuters.

Strategies, Trends
and Forecasts

19

Number of Biologic Product Based Deals 2000-2011

250

200

150

100

50

20

First Wave Biosimilar Deals: EPO, G-CSF

Apotex & Cangene (1999), BioGeneriX (1999), Intas (2005)

Ratiopharm via BioGeneriX (2003)
Hospira via STADA (2006)

Barr via Pliva (2005)

Lupin via Bharat (2006)
Mayne via Pliva (2005)

Teva via Savient (1999), Sicor/UAB (1999), IVAX (2004), Tianjin Hualida
(2006)
STADA via DSM Biologics (2001), Bioceuticals (2001)
Sandoz in-house

Source: TR Research
21

Biologic Manufacturing, Supply & Distribution Deals, 2000-2011

100
90
80
70

60
50
40
30
20

10
0
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
22

2nd Wave Biosimilar Technology Acquisition

Mylan via Biocon (2009)

Hospira via BresaGen (2006), HGS (2008), Celltrion (2009), Pliva
(2009)
Teva via CoGenesys (2008), Lonza (2009)
Pfizer via Biocon (2010)
Strides via Inbiopro (2010)
Kemwell joint venture with Boehringer Ingelheim (2010)
Gedeon Richter via Mochida (2010)
Cipla joint venture with BioMab (2010)
EGIS via Celltrion (2010)
Watson via Itero (2010)
Shenzhen Wanle via Celltrion (2010)

Source: TR Research
23

The Trend Continues in 2011

Merck via Parexel, Hanwha

Viropro via Spectrum

Samsung via Quintiles
Fujifulm via Merck Biomanufacturing Network
Lupin via Nueclone
Compass Biotechnologies via PanGen Biotech
Pharma Praxis and Brazils Ministry of Health
Mochida, Fuji

Natco via Mabxience

24

Number of Biologic Product Based Deals 2000-2011

Biologics v Biosimilars
250
200
150
100

Biologics
Biosimilars

50
0

25

Teva: A Case Study

Year

Deal Activity

Impact

2004

Purchased SICOR

Biologics Facility

2005

Purchased Tianjin Hualida

IFN Producer

2006

Collaboration with Protalix

Novel Expression

2008

Purchased CoGenesys

Albumin Infusion

2009

Alliance with Lonza

Experience

26

Competitive Advantages Through Strategic Deals

Current strategies for companies investing in

follow-on biologic development focus on novel
technologies and manufacturing experience.
Improved efficacy and safety of products that
employ these new technologies and
manufacturing practices will increase incentive for
innovative process development.
Strategic deals will focus on additional solutions
that will provide a competitive advantage in the
follow-on biologic market in the U.S. and globally

27

Conclusions and Considerations

A new paradigm in pharma competition

Global markets and regulations growing to meet
domestic demand and international growth

Uncertainty remains and will effect decision

makers but not development and less regulated
market launches
IP considerations and strategies will become
defined.

28

Further
information
Thank You!

Andrew Fischer Bourgoin

Pharmaceutical Research Analyst
Thomson Reuters Healthcare & Science

Andrew.Bourgoin@thomsonreuters.com

White Paper on US Follow-on Biologic Competition

http://science.thomsonreuters.com/info/newport_whitepapers/

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