ブラジルにおける生物学的同等性ジェネリック医薬品の機会と課題

Abstract

This new report puts the generic market in context, providing a review of the regulatory environment, the major domestic manufacturers, market analysis and five-year market forecasts to 2012.

The world’s major emerging economies are attracting much investment and interest. Brazil is not least among them, and it is easy to see why with a population of 189 million and a GDP of US$978 billion in 2007.

But there are particular attractions for the producers of generic pharmaceuticals. For years the “generic” market was little more than a series of copycat products, similar to the branded product but not necessarily bioequivalent. Under increasing pressure from industry to respect patents, and with one eye on the need to cost effectively meet the growing health needs, the Brazilian authorities have led the way in the region in creating a market for truly bioequivalent generic drugs which now ranks in the top ten worldwide.

The generics market, already in a strong growth phase, is well placed to continue its future expansion. The generic production of oral contraceptives and endogenous hormones was approved in March 2007, a number of leading brands are due to lose their patent protection over the next 5 years and the use of generic drugs is expected to grow as price pressures bite.

But who are the leading players and what are their strengths? What barriers to market entry exist? What routes to market are favourable? What will be the operating and regulatory environment for companies? The answers to these and many other questions can be found in this new 200-page management report Opportunities and Challenges for Bioequivalent Generic Drugs in Brazil (Published April 2007).

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