Biosimilar Products
in Brazil
Edilson Uiechi
Government Affairs
Libbs Pharmaceutical
RANK 2017
1 UNITED STATES
2 CHINA
3 JAPAN
4 BRAZIL
5 GERMANY
6 FRANCE
7 ITALY
8 RUSSIA
9 INDIA
10 CANADA
11 UK
12 SPAIN
13 AUSTRALIA
14 ARGENTINA
15 SOUTH KOREA
16 MEXICO
17 TURKEY
18 INDONESIA
19 VENEZUELA
20 POLAND
RANK
BRAZIL
10º 2007
6º 2012
4º 2017
Institutional
Farmacêutica
Unidade B2B (JAN-DEZ 2013)
Faturamento: R$ 271 mi
Farmacêutica
Unidade B2C (JAN-DEZ 2013)
Faturamento: R$ 777,3 mi
Farmoquímica (JAN-DEZ 2013)
Faturamento: R$ 50,6 mi
Business Units
Therapeutic specialties
Gynecological
Cardiovascular
NCS
Dermatology
Respiratory
Oncology
Transplants
other specialties
Global Quality - Active pharmaceutical
ingredients for Europe and Mercosul
Tibolone
Mazindol
Gestodeno
• Production
• 20 APIs
• R&D
Pathways for innovation
2005
2010
2013
“Innovation”
Marketing opportunities; small differences
Incremental innovation New associations, new in Brazil, technological barriers
Rupture New molecules, New therapies
Networking of development and
Innovation - Partnerships
USA
BRAZIL
LATIN AMERICA
EUROPE
SPAIN ASIA
Investiment em R,D&I
28,4 28,6 31,2 46 48,4
88,5
153,5*
0
20
40
60
80
100
120
140
160
180
2008 2009 2010 2011 2012 2013 2014
9,2 8,11 7,67
9,33
5,98
9,74
14*
0
2
4
6
8
10
12
14
16
2008 2009 2010 2011 2012 2013 2014
Investiment em R,D&I - R$ M % invoicing
*estImative
Investiment 2014-2017
MM R$
R$ 1,258 bi
4y
R&D
529 Biotec
378 Infra
351
Biotec Unit
• 400kg/ano of MABs
• Single use Technology
• First GMP Batch -2016 • FDA
• EMA
• ANVISA
Libbs industrial Complex
Biosimilars Tech Transfer
Patient Access
Biobetters
Inovators
WHY BIOSIMILAR FOR LIBBS?
Development and
Production
Synthetic Drugs
Development
and Production
Pharmaceutical Active
(API)
Technological
Knowledge Incorporation of
technology
Biobetters
&
Innovators National
strengthening of the
medicines
production
Biosimilar • Human resource
and knowledge
• Biological
Production
Networking of development and Innovation
Growing of Innovation Network and Partners
Worldwide
USA
BRAZIL
LATIN AMERICA
EUROPE
SPAIN ASIA
Edilson Uiechi Government Affairs Manager
Tel.: 55 (11) 3879 2500
www.libbs.com.br
THANK YOU!