Biogenerics

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

II. EXECUTIVE SUMMARY

1. Market Overview

• Biogenerics Spell Opportunities
• Patent Expiration of Biotech Medicines Paves Way for New Generation Biogenerics
• Patent Expiration of Major Biotechnology Products before 2007
• Market Structure
• Potential Key Competitors in the Biogenerics Space
• Entry Barriers for Biogenerics
• Comparison of Entry Barriers for Biogenerics in Select Global Markets
• Is Commercialization of Biogenerics Possible?
• Will Biopharmaceutical Market Witness Intense Competition from Generic Firms?
• Branded Vs Generics Drugs - The Debate Continues
• Growth Impediments
• Heavy Investment
• Shortage of Manufacturing Capacity
• Lack of Clear Regulatory Mechanism
• Overview of Select Markets
• United States
• Biogenerics to Exhibit Slow Start
• Europe
• Australia
• India - Emerging Player in the Biogeneric Market

2. Trends and Issues

• US FDA Under Pressure
• Entry Barriers Limit Competition in Biogenerics Market
• Bend the Rule or Not - Authorities in Dilemma
• Biogenerics Market Gains Support from Other Institutions
• Generic Drug Producers Adopt "Evergreening" Concept
• Biogenerics Need to Conform to the Production Norms of Original Products

3. Drug Approval Process in US and Europe

• Bioequivalence Tests - Mandatory Requirement for Generics
• Approval Process in the US
• Hatch Waxman Act and FDA Approval Process
• ANDA Review Process
• Generic Exclusivity
• 30-Month Stay Period
• 180-Days Exclusivity Period7
• Time Period for Generic Approval
• Approval Process in Europe
• Generic Companies Face Strict Regulations for Approval
• Data Exclusivity

4. Product Overview

• What are Biogenerics?
• Biogenerics - Generic Version of Biopharmaceuticals
• Biopharmaceuticals
• Biogenerics Versus Conventional Generics
• Manufacturing Process of Biogenerics -
• A Debatable Issue

5. Recent Industry Activity

• Teva Acquires IVAX Corporation
• Biopartners Bags EU Marketing Approval for Valtropin
• Sandoz Bags EC Marketing Approval for Omnitrope
• Omnitrope Receives US FDA Approval
• Biocon Limited Partners with Vaccinex Inc
• Novartis Pockets Hexal AG
• Mayne' s Pharma Division Collaborates with Pliva
• Clinigene Initiates Clinical Trials on Biocon' s EGFRMonoclonal Antibody
• Barr Laboratories Signs Agreement with Pliva for Developing G-CSF
• Pliva Croatia Bags Approval for Biogeneric EPO
• Teva Pharmaceutical Industries Acquires SICOR
• Biocon Launches Bio-Insulin
• Cipla in Strategic Alliance with Dongbao PharmaceuticalCompany Ltd
• Crucell N.V. Signs a Licensing Agreement with Gene Medicine Japan Inc

6. Focus on Select Players

• Biocon Limited (India)
• BioPartners (Switzerland)
• BioGeneriX AG (Germany)
• Cangene Corporation (Canada)
• Cipla Ltd. (India)
• Dr. Reddy' s Laboratories (India)
• GeneMedix (UK)
• LG Life Sciences (Korea)
• Pliva d.d. (Croatia)
• Ranbaxy Laboratories Limited (India)
• Sandoz International GmbH (Germany),
• a Unit of Novartis
• Stada Arzneimittel (Germany)
• Teva Pharmaceutical Industries Ltd. (Israel)
• Teva Pharmaceuticals USA (USA)
• Wockhardt Limited (India)

7. Global Market Perspective

• Table 1: Worldwide Market for Biogenerics - Market Projections for US, Europe and Rest of World with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart)
• Table 2: Worldwide 6-Year Perspective for Biogenerics - Percentage Breakdown of Dollar Sales for US, Europe and Rest of World for Years 2007, 2010 & 2013 (includes corresponding Graph/Chart)

III. COMPETITION

• 1. Anhui Anke Bio Tech (China)
• 2. Barr Laboratories, Inc. (USA)
• 3. Bharat Biotech International Limited (India)
• 4. Biocon India Limited (India)
• Table 3: Annual Sales Analysis: 2004-2005 (In INR million)
• Clinigene (India)
• 5. Biogenerics GmbH (Germany)
• 6. Biogenerics Pharma (USA)
• 7. BiogeneriX AG (Germany)
• 8. Biopartners (Switzerland)
• 9. Cangene Corporation (Canada)
• Table 4: Nine Months Sales Analysis: 2005-2006(Nine Months Ended, April) (In Can$ million)
• Table 5: Nine Months Sales Analysis by Quarter: 2005-2006 (Nine Months Ended, April) (In Can$ million)
• Table 6: Annual Sales Analysis: 2003-2005 (In Can$ million)
• Table 7: Annual Sales Analysis by Geographic Region: 2004-2005 (In Can$ million)
• 10. CIGB (Cuba)
• 11. Cipla Ltd. (India)
• Table 8: Annual Sales Analysis: 2003-2005 (In INR billion)
• Table 9: Annual Sales Analysis by Quarter: 2004-2005 (In INR billion)
• 12. Crucell NV (The Netherlands)
• Table 10: First Quarter Sales Analysis: 2005-2006 (In € million)
• Table 11: Annual Sales Analysis: 2004-2005 (In € million)
• Table 12: Annual Sales Analysis by Geographic Region: 2004-2005 (In € million)
• 13. Dr. Reddy' s Laboratories Ltd. (India)
• Table 13: Annual Sales Analysis: 2004-2006 (In INR billion)
• Table 14: Annual Sales Analysis by Segment: 2004-2005 (In INR billion)
• Table 15: Annual Sales Analysis by Geographic Region: 2004-2005 (In INR billion)
• 14. Dragon Pharmaceuticals, Inc. (USA)
• 15. Eli Lilly And Company (USA)
• Table 16: First Quarter Sales Analysis: 2005-2006 (In US$ million)
• Table 17: First Quarter Sales Analysis by Segment: 2005-2006 (In US$ million)
• Table 18: First Quarter Sales Analysis by Product: 2005-2006 (In US$ million)
• Table 19: Annual Sales Analysis: 2003-2005 (In US$ Billion)
• Table 20: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)
• Table 21: Annual Sales Analysis by Product: 2004-2005 (In US$ million)
• Table 22: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)
• 16. Ferring Pharmaceuticals (USA)
• 17. Gene Medicine Japan, Inc. (Japan)
• 18. GeneMedix PLC (UK)
• 19. Inno Biologics Sdn. Bhd. (Malaysia)
• 20. Insight Biopharmaceuticals Ltd. (Israel)
• 21. Intas Pharmaceuticals Ltd. (India)
• 22. LG Life Sciences (Korea)
• 23. Mayne Pharma PLC (UK)
• 24. Merck KGAA (Germany)
• Table 23: Annual Sales Analysis: 2003-2005 (In € million)
• Table 24: Annual Sales Analysis by Segment: 2004-2005 (In € million)
• 25. Microbix Biosystems, Inc. (Canada)
• Table 25: Half Yearly Sales Analysis: 2005-2006 (H1) (In US$ million)
• Table 26: Annual Sales Analysis: 2004-2005 (In US$ million)
• Table 27: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)
• 26. Migenix, Inc. (Canada)
• Table 28: Annual Sales Analysis: 2003-2005 (In US$ million)
• Table 29: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)
• 27. Momenta Pharmaceuticals, Inc. (USA)
• Table 30: First Quarter Sales Analysis:2005-2006 (In US$ million)
• Table 31: Annual Sales Analysis: 2003-2005 (In US$ million)
• 28. Neose Technologies, Inc. (USA)
• Table 32: First Quarter Sales Analysis: 2005-2006 (In US$ million)
• Table 33: Annual Sales Analysis: 2003-2005 (In US$ million)
• Table 34: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)
• 29. Novartis AG (Switzerland)
• Table 35: First Quarter Sales Analysis: 2005-2006 (In US$ million)
• Table 36: First Quarter Sales Analysis by Segment: 2005-2006 (In US$ million)
• Table 37: Annual Sales Analysis: 2003-2005 (In US$ million)
• Table 38: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)
• Table 39: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)
• Sandoz International GmbH (Germany)
• Sandoz, Inc. (USA)
• 30. Novo Nordisk A/S (Denmark)
• Table 40: Annual Sales Analysis: 2003-2005 (In DKK million)
• Table 41: Annual Sales Analysis by Segment: 2004-2005 (In DKK million)
• Table 42: Annual Sales Analysis by Geographic Region: 2004-2005 (In DKK million)
• 31. Pfizer, Inc. (USA)
• Table 43: Annual Sales Analysis: 2003-2005 (In US$ billion)
• 32. Pliva D.D. (Croatia)
• Table 44: Annual Sales Analysis: 2003-2005 (In US$ million)
• Table 45: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)
• Table 46: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)
• 33. Ranbaxy Laboratories Ltd. (India)
• Table 47: First Quarter Sales Analysis: 2004-2005 (In INR billion)
• 34. Savient Pharmaceuticals, Inc. (USA)
• Table 48: First Quarter Sales Analysis: 2005-2006 (In US$ million)
• Table 49: Annual Sales Analysis: 2004-2005 (In US$ million)
• Table 50: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)
• 35. Shantha Biotechnics Limited (India)
• 36. Shenyang Sunshine Pharmaceutical Co., Ltd. (China)
• 37. Stada Arzneimittel AG (Germany)
• Table 51: Annual Sales Analysis: 2003-2005 (In € million)
• Table 52: Annual Sales Analysis by Segment:2004-2005 (In € million)
• Table 53: Annual Sales Analysis by Geographic Region: 2004-2005 (In € million)
• 38. Teva Pharmaceutical Industries Ltd. (Israel)
• Table 54: First Quarter Sales Analysis: 2005-2006 (In US$ billion)
• Table 55: Annual Sales Analysis: 2003-2005 (In US$ billion)
• Teva Pharmaceuticals (USA)
• Sicor, Inc. (USA)
• 39. Vaccinex, Inc. (USA)
• 40. Wockhardt Ltd. (India)
• Table 56: Annual Sales Analysis: 2003-2005 (In INR billion)
• 41. Zenotech Laboratories Ltd. (India)
• Table 57: Annual Sales Analysis: 2003-2005 (In INR million)
• 42. Zydus Cadila (India)
• Table 58: Annual Sales Analysis: 2004-2005 (In INR million)