THE RISE OF A NATIONAL BIOPHARMACEUTICAL

INDUSTRY IN BRAZIL: CONSOLIDATION AND NEXT

STEPS.

An Update/Overview on Regulatory Convergence, Predictability, Transparency and Priority Reviews

Monday, 24th of August

Reginaldo Braga Arcuri

Non-profit association of nine brazilian pharmaceuticalcompanies focused on innovation and development of newproducts through international standards and high-qualityresearch.

GRUPO FARMABRASIL

Improving Management and Legal Frameworkfor Innovation

Expanding accessto medicines

Through increasingNational supply

I N N O V A T I O N

GRUPO FARMA BRASIL STRATEGIC GOALS

Consolidating a National

PharmaceuticalIndustry based on the

existing portfolio and new Products.

RISE AND CONSOLIDATION OF A BRAZILIAN

PHARMACEUTICAL INDUSTRY

Creation, maintenance and expansion of supporting policies

BUILDING AN INDUSTRY

Creation of Anvisa

GenericDrug Law

Patent Law

Biotechnology

New PathNew Skills

Manufacturing Plants

(biologics)

Biosimilars

New Biologics

Syntheticdrugs

ContinuedpathAccumulated

experienceand skills

New Molecules

2013

Incremental Innovation

Certified GMP manufacturing

facility

Generic Drugs

2003

Paths drawn by BNDES

VISION OF THE FUTURE OF BRAZILIAN PHARMACEUTIRCAL INDUSTRY

Source: Pedro Palmeira/BNDES

HEBRONBIOTECNOLOGIA

*BIONOVIS

•R$ 739 million

•7 PDP’s for Biologics

•R$ 100 million

•3 PDP’s forBiologics

*CRISTÁLIA BIOTECNOLOGIA

•R$500.8 million

•Plant will start operations in 2016

•6 PDP’s for Biologics

*LIBBS BIOTECNOLOGIA

•R$500 million

•4 PDP’s for Biologics

*ORYGEN

BIOTECNOLOGIA

BIOLOGICS: R$ 1,4 billion**

0.79%

2.39%

6.00%

0.00%

1.00%

2.00%

3.00%

4.00%

5.00%

6.00%

7.00%

Brasil Produtosfarmoquímicos e

farmacêuticos

Grupo FarmaBrasilPharmachemical and pharmaceutical products

Fonte: IBGE, 2011 e Grupo FarmaBrasil. Elaboração própria.

Last 5 years: = R$ 2.5 billion

Projection for the next 5 years: =

R$ 5 billion

% of net income invested in R&D:

:SYNTHETICS:

•R$ 50 million

• Companies with BNDES and FINEP contribution

** Investments from 2014

RESPONSE OF THE BRAZILIAN PHARMACEUTICAL INDUSTRY: INVESTMENTS

Tech Transfer Partners for biotech drug manufacturing in Brazil:

PRODUCTIVE DEVELOPMENT PARTNERSHIPS (PDPS)

GRUPO FARMABRASIL IN THE PDP PROGRAM

PRODUCTIVE DEVELOPMENT PARTNERSHIPS (PDPS)

GRUPO FARMABRASIL IN THE PDP PROGRAM

31 Partnerships for developing and

manufacturing Biologic Drugs

23 biologic drugs including second

and third-generation biologic drugs

Currently procurement of these

drugs is around R$ 1,8 billion

Savings of R$ 225 million/year

cancer rheumatoid arthritis diabetes surgical tissue adhesive growth hormone allergy vaccine

Source: Brazilian Ministry of Health

Deficit reduction on trade balance of US$ 900 million

32%

68%

Outros Parceiros Grupo FarmaBrasilOthers

Expansion to American Continent

FOUNDATIONS FOR THE FUTURE

Eurofarma Colômbia/Fábrica MSD

Eurofarma Peru

Eurofarma Chile

Cristália/IMA Argentina

Eurofarma Argentina

Eurofarma Uruguai

Brace Farma (EMS)

Hebron Del Peru

Eurofarma Bolívia

Eurofarma Centro-América

Eurofarma/Melinta

Libbs

Hebron USA

Biolab

Biolab

NEXT STEPS

IMPROVING REGULATION FOR BIOTECH DRUGS

NEXT STEPS TO BIOTECH DEVELOPMENT IN BRAZIL

Create the opportunity for companies to discuss their DevelopingPlans for biotech drugs with the regulatory agency, ANVISA,guarantying more legal and regulatory certainty to the undergoinginvestments.

Regulate “Good manufacturing practices (GMP)”, specifically tobiological drugs.

Elaborate Guidelines for Registration and Post registration ofbiological drugs.

BRAZILIAN PHARMACEUTICAL

INDUSTRY HAS BEEN GROWING INTO

A WORLD CLASS INDUSTRY

Reginaldo ArcuriExecutive President

Adriana Diaferia Executive Vice President

+55 61 3224-2003

contato@grupofarmabrasil.com.br

SBS, Quadra 02, Bloco E, nº 12, 15º andar, Salas nº 1501 e 1502,

Edifício Prime Business Convenience, CEP 70.070-120 - Brasília/DF

THANK YOU