TABLE OF CONTENTS
FOREWORD
EXECUTIVE SUMMARY
- What is a biologic drug?
- What is a biogeneric?
- Why are biogenerics an issue?
- Growth of US pharmaceutical expenditure
- Obstacles
- Political
- Regulatory
- Scientific
- USP publishes monographs on somatropin
- Comparability; branded industry precedent?
- Immunogenicity
- Legal
- Patent challenges
- Exclusivity of test data
- Commercial
- Will the cost of getting a biogeneric approved make it financially worthwhile?
- Threat of authorised generics
- Obsolescence of older products
- Cultural
- Regional Market Prospects
- USA
- Canada
- EU
- Australia
- Japan
- China
- Other ess-regulated markets
- Manufacturing Overview
- USA
- Canada
- Europe
- India
- China
- Korea
- Cuba
BIOGENERIC MARKET ENVIRONMENT IN THE USA
- Hatch Waxman is not applicable to biologics
- Exceptions?
- FDA transfer of biologic responsibility to CDER
- Is the 505(b)(2) route feasible?
- BIO Citizen Petition against 505(b)(2)
- Omnitrope 505(b)(2) submission
- Genentech Citizen Petition against 505(b)(2)
- Pfizer Citizen Petition against approval of Omnitrope
- Easier not to seek an abridged application?
- Senate Hearing, June 2004
- Amgen testimony
- GPhA testimony
- FDA testimony
- Parallel trade issues
- Conclusion
BIOGENERIC MARKET ENVIRONMENT IN THE EUROPEAN UNION
- The new EU approval process
- Regulation of biosimilars
- 2005 EMEA Guideline Documents
- EPO
- G-CSF
- Somatropin
- rH Insulin
- Omnitrope
- Patent protection/data exclusivity
- New Bolar provision
- Attempt to create a single EU Patent fails
LIKELY BIOGENERIC PRODUCTS
- English Biologic Prescription Data, 2003-04
- Erythropoietin (EPO)
- PRCA incidence
- Procrit/Eprex
- Epogen/Aranesp
- Neorecormon/Epogin
- Epogin
- Biogeneric versions
- Human Growth Hormone (hGH, somatropin)
- Genotropin .
- Humatrope
- Norditropin/other Novo Nordisk hGH products
- Nutropin/other Genentech hGH products
- Saizen/Serostim
- Biogeneric versions
- G-CSF/GM-CSF
- Neupogen/Neulasta
- Neutrogin/Granocyte
- Leukine
- Biogeneric versions
- Recombinant insulin
- Novo Nordisk recombinant insulin products
- Eli Lilly recombinant insulin products
- Aventis recombinant insulin product: Lantus
- Biogeneric versions
- Interferon
- Schering Plough Interferon A (Intron A range)
- Roche Interferon A range (Roferon/Pegasys)
- Betaseron/Betaferon
- Avonex
- Rebif
- Biogeneric versions
MANUFACTURER PROFILES
- Anhui Anke Biotech
- Biocon
- BioGeneriX
- Cangene
- Neose Technologies
- BioPartners
- Cangene
- CIGB (Cuba)
- Cipla
- CheilJedang (CJ Corp)
- Dr Reddy s
- Dragon Pharmaceuticals
- Merger with Oriental Wave Holdings
- EPO
- G-CSF
- Sales data
- GeneMedix
- Inno Biologics
- LG Life Sciences
- Microbix
- Momenta Pharmaceuticals
- Pliva
- EPO, Croatian approval granted
- G-CSF, agreement with Barr Laboratories
- Mayne Pharma
- Sandoz
- Lek
- Sandoz biotech plants, Austria
- Lek biotech plant, Slovenia
- Savient Pharmaceuticals
- Savient Sells Biologics Division to Ferring
- Shenyang Sunshine Pharmaceutical Co Ltd
- Shenzhen Kexing Biotech
- Stada Arzneimittel
- Teva Pharmaceuticals
- Tev Tropin
- Sicor
- Tianjin Hualida Biotechnology Pharmaceutical Co
- Wockhardt
APPENDIX: GENERIC MARKET DATA
SOURCES
DIRECTORY
- Regulators
- Industry Associations
- Manufacturers
INDEX OF TABLES
- US Research-Based Pharmaceutical Manufacturers Sales, 1990-2004 (US$ millions)
- Pharmaceutical Expenditure as % of GDP, 1990-2004
- Growth of Medicaid Pharmaceutical Expenditure, 1997-2003 (US$ millions)
- Major Countries where Biogenerics are Currently Marketed
- Biogeneric Products Developed/Under Development by Company
- Biogeneric Products Marketed by Company
- Summary Branded Sales Data for Leading Biotech Products, 2001-04 (US$ millions)
- Summary Branded Sales Data for leading Biotech Products, 2002-04 (% Change)
- J&J Sales of Procrit/Eprex, 2001-2004 (US$ millions)
- Amgen Sales of Epogen/Aranesp, 2001-2004 (US$ billions)
- Roche Sales of Neorecormon/Epogin, 2002-2004 (SwF millions)
- Epogin Sales in Japan, 2002-03 (\ billion)
- Genotropin Sales, 2001-04 (US$ millions)
- Humatrope Sales, 2001-04 (US$ millions)
- Novo Nordisk hGH Sales, 2001-04 (DKK millions)
- Genentech hGH Sales, 2001-04 (US$ millions)
- Serono hGH Sales, 2001-2004 (US$ millions)
- Neupogen/Neulasta Sales, 2001-04 (US$ billions)
- Sales of Neutrogin/Granocyte, 2002-04 (billion yen)
- Sales of Insulin Analogues, 2001-2004 (DKK million)
- Sales of Humulin and Humalog, 2001-2004 (US$000s)
- Sales of Lantus, 2001-2004 (euro millions)
- Sales of Intron A (including PEG-Intron), 2001-2004 (US$ millions)
- Sales of Pegasys, 2002-04 (SwF millions)
- Sales of Betaseron/Betaferon, 2001-04 (euro millions)
- Sales of Avonex, 2001-04 (US$ millions)
- Sales of Rebif, 2001-04 (US$ millions)
- Dragon Pharmaceutical revenues, 2003-04 (US$ millions)
- Dragon Pharmaceutical revenues by Segment, Q1 2005 (US$ millions)
- Countries by Population (millions)
- GDP per capita, US$
- Health Expenditure per capita (US$)
- Health Expenditure as % of GDP
- Hospital Beds per 000 Population
- Physicians per 000 Population
- Total Pharmaceutical Market, (US$ billions)
- Total Pharmaceutical Expenditure Per Capita, (US$)
- Generic Pharmaceutical Markets (US$ millions)
- Generic Pharmaceutical Expenditure per capita, (US$)
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