Biologics Market: An Overview
Developments, Trends and Strategies
ANDREW BOURGOIN
Andrew.Bourgoin@thomsonreuters.com
NY Pharma Forum
January 31st, 2012
Generics & API Intelligence at Thomson Reuters
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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/
29
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