Opportunities and Challenges for Bioequivalent Generic Drugs in Brazil

Table of Contents

FOREWORD

EXECUTIVE SUMMARY

REGULATORY ENVIRONMENT OF GENERIC MEDICINES IN BRAZIL

• Regulation of Generic Medicines
  • Regulation of Similar Medicines
  • Future Regulation of Biosimilar Medicines
• Registration of Generic Medicines
  • How to Register Generic Medicines
  • Centres to Perform Bioquivalence Studies
  • Registrations of Generic Medicines
• Marketing Authorisations of Generic Medicines
• Labelling & Packaging of Generic Medicines
  • Proposal to Include the Reference Drug Name
  • Indian Producer Targeting Packaging of Generic Medicines
• Patent Protection & Intellectual Property Rights
  • Lobbying Against Patent Extensions in the Pipeline System
  • Deal Agreed to Reduce the Price of Abbott’s Kaletra
• Pricing Policies
  • Implications for the Industry
  • Excessive Taxes on Drugs
  • New Drug Discounts in the Public Sector
  • Pricing of Generic Medicines

OVERVIEW OF THE GENERICS MARKET IN LATIN AMERICA

OVERVIEW OF THE PHARMACEUTICAL MARKET IN BRAZIL

MARKET FOR GENERIC MEDICINES IN BRAZIL

• Sales of Generic Medicines in the Pharmacy Sector
• Market Projections for Generic Medicines
• Market Outlook for Generic Medicines
  • Production of Oral Generic Contraceptives & Hormones
  • More Uniform Market Penetration Across all the Regions
  • Unsustainable Reliance on Original HIV/AIDS Medicines
  • Foreign Generic Producers Squashed by Local Competition
  • Sales Strategies Devised by Producers of Generic Medicines
  • Potential Government Production of Bioequivalent Generic Medicines
  • Original Drugs with Patents Close to Expiry
  • Challenges in the Public Sector
  • Teva’s Acquisition Possibilities in Brazil
  • Generics, High Cost Savings but Low Prescription Levels
• Domestic Production of Generic Medicines
  • Pólo Farmoquímico de Goiás
  • Investments Undertaken by Producers of Generic Medicines
  • Relevant Trade Associations
    • ALANAC
    • ALFOB
    • Pró-Genéricos

DOMESTIC PRODUCERS OF GENERIC MEDICINES IN BRAZIL

• Aché
  • Product Portfolio
    • Biosintetica’s Product Portfolio
  • Financial Indicators
    • Biosintética’s Financial Indicators
  • R&D
  • Manufacturing Capabilities
    • Biosintética’s Manufacturing Capabilities
  • Contact Details
• Americano de Farmacoterapia (FARMASA)
  • Product Portfolio
  • Financial Indicators
  • R&D
  • Manufacturing Capabilities
  • Contact Details
• Arrow (Erowlabs)
  • Product Portfolio
  • Manufacturing Capabilities
  • Contact Details
• Brainfarma
  • Product Portfolio
  • Financial Indicators
  • Manufacturing Capabilities
  • Contact Details
• Cimed
  • Product Portfolio
  • Financial Indicators
  • R&D
  • Manufacturing Capabilities
  • Distribution Facilities
  • Contact Details
• Cristália
  • Product Portfolio
  • Financial Indicators
  • R&D
  • Manufacturing Capabilities
  • Contact Details
• EMS Sigma Pharma
  • Product Portfolio
  • Financial Indicators
  • R&D
  • Manufacturing Capabilities
  • Contact Details
• Eurofarma
  • Product Portfolio
  • Financial Indicators
  • R&D
  • Manufacturing Capabilities
  • Contact Details
• Hipolabor
  • Product Portfolio
  • Manufacturing Capabilities
  • Contact Details
• LAFEPE
  • Product Portfolio
  • Financial Indicators
  • Manufacturing Capabilities
  • Contact Details
• Medley
  • Product Portfolio
  • Extended Exclusivity Deal with Abbott
  • International Agreements
  • Financial Indicators
  • Manufacturing Capabilities
  • Contact Details
• Neo Química
  • Product Portfolio
  • Financial Indicators
  • R&D
  • Manufacturing Capabilities
  • Distribution Facilities
  • Contact Details
• Prati, Donaduzzi
  • Product Portfolio
  • Manufacturing Capabilities
  • Contact Details
• Teuto
  • Product Portfolio
  • Financial Indicators
  • Manufacturing Capabilities
  • Contact Details
• União Química
  • Product Portfolio
  • Financial Indicators
  • Manufacturing Capabilities
  • Contact Details

MULTINATIONAL PRODUCERS OF GENERIC MEDICINES IN BRAZIL

• Abbott
  • Product Portfolio
  • Manufacturing Capabilities
  • Contact Details
• Apotex
  • Product Portfolio
  • Contact Details
• Mepha - ratiopharm
  • Product Portfolio
  • Financial Indicators
  • Planned Manufacturing Capabilities
  • Contact Details
• Merck KGaA
  • Product Portfolio
  • Financial Indicators
  • Production Capabilities
  • Contact Details
• Ranbaxy
  • Product Portfolio
  • Financial Indicators
  • Manufacturing Capabilities
  • Contact Details
• Sandoz
  • Product Portfolio
  • Financial Indicators
  • Production Capabilities
  • Contact Details

KEY NATIONAL DATA PROJECTIONS

APPENDICES

DIRECTORY

• Government Organisations
• Producers of Generic Medicines
• Trade Associations

List of Tables

• National Bioequivalence Centres Authorised by ANVISA, 2007
• International Bioequivalence Centres Authorised by ANVISA, 2007
• Active Ingredients, Registrations & Presentations of Generic Medicines, 2000-2006
• Cumulative Active Ingredients, Registrations & Presentations of Generics, 2000-2006
• Registrations of Generic Medicines by Product Type, 2006
• Registrations of Generic Medicines by Product Type, 2006 (%)
• Registrations of Generic Medicines by Origin, 2006
• Registrations of Generic Medicines by Producer, 2006
• Original Drugs with the Highest Number of Generic Registrations, January 2007
• Producers with Generic Registrations of Leading Original Drugs, January 2007
• Marketing Authorisations of Generic Medicines by Producer, July 2006
• Registrations & Marketing Authorisations of Generics by Producer, 2006
• Drugs with the Highest Number of Generics Marketing Authorisations, July 2006
• Producers with Generic Marketing Authorisations to Leading Drugs, July 2006
• Marketed Active Ingredients, Registrations & Presentations of Generics, 2005
• Marketed Generic Medicines by Origin, July 2005
• Drug Price Adjustments, 2003-2006 (%)
• Pharmacy & Generics Sales by Leading Latin American Country, 2006 (US$ Million)
• Pharmacy & Generics Sales by Leading Latin American Country, 2006 (%)
• Pharmacy & Generics Sales by Leading Latin American Country, 2006 (Million Units)
• Pharmacy & Generics Sales by Leading Latin American Country, 2006 (%)
• Summary of the Brazilian Pharmaceutical Market, 2007
• Brazilian Pharmaceutical Market by Value & Volume, 1997-2006
• Brazilian Pharmacy Sector by Value & Volume, 2003-2006
• Brazilian Pharmacy Sector by Value, 1997-2005
• Pharmacy Sales of Generic Medicines by Value, 2000-2006
• Pharmacy Sales of Generic Medicines by Leading Producer, 2006
• Pharmacy Sales of Generic Medicines by Origin, 2006 (%)
• Pharmacy Sales of Generic Medicines by Volume, 2000-2006
• Sales of Generic Medicines by Month as % of the Pharmacy Sector, 2005-2006
• Generics Market Projections, 2007-2012
• Generics & Total Pharmaceutical Market Projections, 2007-2012 (US$ Billion)
• Original Drugs with Patent Close to Expiry, 2006-2013
• SWOT Analysis of the Market of Generic Medicines, 2007
• Workforce by Leading Producers of Generic Pharmaceuticals in Goiás
• Members of ALANAC, 2006
• Members of ALFOB, 2006
• Pró-Genéricos’ Members, 2007
• Aché’s Leading Products by Therapeutic Area, 2005
• Aché & Biosintética’s Therapeutic/Product Areas, 2005
• Biosintética’s Registrations & Marketing Authorisations of Generic Medicines, 2006
• Aché’s & Biosintética’s Gross Revenues by Therapeutic Areas, 2005
• Biosintética’s Sales, 2001-2004
• Biosintética’s Pharmaceutical Sales by Therapeutic Areas, 2004
• Americano’s Registrations & Marketing Authorisations of Generic Medicines, 2007
• Erowlabs’ Registrations & Marketing Authorisations of Generic Medicines, 2007
• Brainfarma’s Registrations & Marketing Authorisations of Generic Medicines, 2006
• Cimed’s Registrations of Generic Medicines, January 2007
• Cristália’s Business Units, 2006
• Cristália’s Registrations & Marketing Authorisations of Generic Medicines, 2006
• EMS’ Generics Registrations & Marketing Authorisations by Division, 2006
• EMS’ Registrations & Marketing Authorisations of Generic Medicines, 2007
• EMS’ Sales by Division, 2006
• Eurofarma’s Generic Medicines, 2005
• Eurofarma’s Pharmaceutical & Generic Sales, 2004-2007
• Hipolabor’s Registrations & Marketing Authorisations of Generic Medicines, 2006
• LAFEPE’s Product Lines, 2007
• Medley’s Registrations & Marketing Authorisations of Generic Medicines, 2007
• Medley’s International Agreements, 1992-2005
• Neo Química’s Registrations & Marketing Authorisations of Generic Medicines, 2007
• Prati, Donaduzzi’s Registrations & Marketing Authorisations of Generics, 2007
• Teuto’s Registrations & Marketing Authorisations of Generic Medicines, 2007
• U. Química’s Registrations & Marketing Authorisations of Generic Medicines, 2007
• Abbott’s Registrations & Marketing Authorisations of Generic Medicines, 2007
• Apotex’s Registrations & Marketing Authorisations of Generic Medicines, 2007
• Mepha’s Registrations & Marketing Authorisations of Generic Medicines, 2006
• Merck’s Registrations & Marketing Authorisations of Generic Medicines, 2007
• Ranbaxy’s Presentations of Generic Medicines, 2007
• Novartis’ (Sandoz) Registrations & Marketing Authorisations of Generics, 2006
• Sandoz’s (Hexal) Registrations & Marketing Authorisations of Generics, 2006
• Key Data, 2007-2012
• Registrations of Generic Medicines by Active Ingredient, January 2007
• Marketing Authorisations of Generic Medicines by Active Ingredient, July 2006

List of Figures

• Bioquivalent Studies, 2002-2005
• Cumulative Active Ingredients, Registrations & Presentations of Generics, 2000-2006
• Cumulative Registrations of Generic Medicines by Therapeutic Area, 2006 (%)
• Registrations of Generic Medicines by Product Type, 2006
• Registrations of Generic Medicines by Foreign Origin, 2006
• Registrations of Generic Medicines by the 20 Leading Producers, 2006
• Marketing Authorisations of Generic Medicines by Leading Producers, July 2006
• Registrations & Marketing Authorisations of Generics by Leading Producers, 2006
• Registrations & Marketing Authorisations of Generics by Leading Producers, 2006 (%)
• Pharmacy & Generics Sales by Leading Latin American Country, 2006 (US$ Million)
• Pharmacy & Generics Sales by Leading Latin American Country, 2006 (%)
• Pharmacy & Generics Sales by Leading Latin American Country, 2006 (Million Units)
• Pharmacy & Generics Sales by Leading Latin American Country, 2006 (%)
• Brazilian Pharmaceutical Market by Value, 1997-2006
• Change in the Brazilian Pharmaceutical Market by Value & Volume, 1997-2006
• Brazilian Pharmacy Sector by Value & Volume, 2003-2006
• Pharmacy Sales of Generic Medicines by Value, 2000-2006
• Pharmacy Sales of Generic Medicines by Volume, 2000-2006
• Sales of Generic Medicines by Month as Percentage of the Pharmacy Sector, 2006
• Generics & Total Pharmaceutical Market Projections, 2007-2012 (US$ Billion)
• Pharmacy Sales of Oral Contraceptives & Hormones, 2006 (%)
• Generics by Region as % of the Pharmacy Sector by Volume, Jan-June 2006
• Generics Sales by Volume & Region, Jan-June 2006 (%)
• Estimated Federal Pharmaceutical Expenditure, 2002-2007
• Prescriptions of Generic Medicines, 2002-2006 (%)
• Cost Savings by Using Generic Medicines, 2001-2006 (US$ Million)
• Producers of Generic Pharmaceuticals in Goiás PharmaChemical Cluster, 2006
• R&D Investments in the Market of Generic Medicines by Type, 1999-2004 (%)
• Aché’s Gross Revenues, 2001-2005 (US$ Million)
• Biosintética’s Sales, 2001-2004
• Cimed’s Sales, 2004-2007
• Eurofarma’s Generics Sales as Percentage of Total Sales, 2004-2007
• Ranbaxy’s Sales, 2003-2006
• Sandoz’s Sales, 2003-2006