Biogenerics

SUMMARY

This report analyzes the worldwide markets for Biogenerics in US$ Million. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual forecasts are provided for each region for the period of 2007 through 2013. The report profiles 42 companies including many key and niche players worldwide such as Biocon Limited, BioPartners, BioGeneriX AG, Cangene Corporation, Cipla Ltd., Dr. Reddy's Laboratories, GeneMedix, LG Life Sciences, Pliva d.d., Ranbaxy Laboratories Limited, Sandoz International GmbH, Stada Arzneimittel, Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA, and Wockhardt Limited. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

TABLE OF CONTENTS

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

II. EXECUTIVE SUMMARY

1. Market Overview II-1

• Biogenerics Spell Opportunities II-1
• Patent Expiration of Biotech Medicines Paves Way for New Generation Biogenerics II-1
• Patent Expiration of Major Biotechnology Products before 2007 II-2
• Market Structure II-2
• Potential Key Competitors in the Biogenerics Space II-2
• Entry Barriers for Biogenerics II-3
• Comparison of Entry Barriers for Biogenerics in Select Global Markets II-3
• Is Commercialization of Biogenerics Possible? II-3
• Will Biopharmaceutical Market Witness Intense Competition from Generic Firms? II-3
• Branded Vs Generics Drugs - The Debate Continues II-3
• Growth Impediments II-4
• Heavy Investment II-4
• Shortage of Manufacturing Capacity II-4
• Lack of Clear Regulatory Mechanism II-4
• Overview of Select Markets II-5
• United States II-5
• Biogenerics to Exhibit Slow Start II-5
• Europe II-5
• Australia II-6
• India - Emerging Player in the Biogeneric Market II-6

2. Trends and Issues II-8

• US FDA Under Pressure II-8
• Entry Barriers Limit Competition in Biogenerics Market II-8
• Bend the Rule or Not - Authorities in Dilemma II-8
• Biogenerics Market Gains Support from Other Institutions II-8
• Generic Drug Producers Adopt "Evergreening" Concept II-8
• Biogenerics Need to Conform to the Production Norms of Original Products II-9

3. Drug Approval Process in US and Europe II-10

• Bioequivalence Tests - Mandatory Requirement for Generics II-10
• Approval Process in the US II-10
• Hatch Waxman Act and FDA Approval Process II-10
• ANDA Review Process II-11
• Generic Exclusivity II-13
• 30-Month Stay Period II-13
• 180-Days Exclusivity Period7 II-13
• Time Period for Generic Approval II-13
• Approval Process in Europe II-13
• Generic Companies Face Strict Regulations for Approval II-13
• Data Exclusivity II-13

4. Product Overview II-15

• What are Biogenerics? II-15
• Biogenerics - Generic Version of Biopharmaceuticals II-15
• Biopharmaceuticals II-16
• Biogenerics Versus Conventional Generics II-17
• Manufacturing Process of Biogenerics -
• A Debatable Issue II-17

5. Recent Industry Activity II-18

• Teva Acquires IVAX Corporation II-18
• Biopartners Bags EU Marketing Approval for Valtropin II-18
• Sandoz Bags EC Marketing Approval for Omnitrope II-18
• Omnitrope Receives US FDA Approval II-18
• Biocon Limited Partners with Vaccinex Inc II-18
• Novartis Pockets Hexal AG II-18
• Mayne's Pharma Division Collaborates with Pliva II-19
• Clinigene Initiates Clinical Trials on Biocon's EGFRMonoclonal Antibody II-19
• Barr Laboratories Signs Agreement with Pliva for Developing G-CSF II-19
• Pliva Croatia Bags Approval for Biogeneric EPO II-20
• Teva Pharmaceutical Industries Acquires SICOR II-20
• Biocon Launches Bio-Insulin II-20
• Cipla in Strategic Alliance with Dongbao PharmaceuticalCompany Ltd II-20
• Crucell N.V. Signs a Licensing Agreement with Gene Medicine Japan Inc II-20

6. Focus on Select Players II-21

• Biocon Limited (India) II-21
• BioPartners (Switzerland) II-21
• BioGeneriX AG (Germany) II-21
• Cangene Corporation (Canada) II-21
• Cipla Ltd. (India) II-21
• Dr. Reddy's Laboratories (India) II-22
• GeneMedix (UK) II-22
• LG Life Sciences (Korea) II-22
• Pliva d.d. (Croatia) II-23
• Ranbaxy Laboratories Limited (India) II-23
• Sandoz International GmbH (Germany),
• a Unit of Novartis II-24
• Stada Arzneimittel (Germany) II-24
• Teva Pharmaceutical Industries Ltd. (Israel) II-25
• Teva Pharmaceuticals USA (USA) II-25
• Wockhardt Limited (India) II-26

7. Global Market Perspective II-27

• 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) II-27
• 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) II-27

III. COMPETITION

• 1. Anhui Anke Bio Tech (China) III-1
• 2. Barr Laboratories, Inc. (USA) III-2
• 3. Bharat Biotech International Limited (India) III-3
• 4. Biocon India Limited (India) III-4
• Table 3: Annual Sales Analysis: 2004-2005 (In INR million) III-5
• Clinigene (India) III-8
• 5. Biogenerics GmbH (Germany) III-9
• 6. Biogenerics Pharma (USA) III-11
• 7. BiogeneriX AG (Germany) III-12
• 8. Biopartners (Switzerland) III-13
• 9. Cangene Corporation (Canada) III-14
• Table 4: Nine Months Sales Analysis: 2005-2006(Nine Months Ended, April) (In Can$ million) III-14
• Table 5: Nine Months Sales Analysis by Quarter: 2005-2006 (Nine Months Ended, April) (In Can$ million) III-14
• Table 6: Annual Sales Analysis: 2003-2005 (In Can$ million) III-15
• Table 7: Annual Sales Analysis by Geographic Region: 2004-2005 (In Can$ million) III-15
• 10. CIGB (Cuba) III-16
• 11. Cipla Ltd. (India) III-17
• Table 8: Annual Sales Analysis: 2003-2005 (In INR billion) III-17
• Table 9: Annual Sales Analysis by Quarter: 2004-2005 (In INR billion) III-18
• 12. Crucell NV (The Netherlands) III-21
• Table 10: First Quarter Sales Analysis: 2005-2006 (In € million) III-21
• Table 11: Annual Sales Analysis: 2004-2005 (In € million) III-22
• Table 12: Annual Sales Analysis by Geographic Region: 2004-2005 (In € million) III-22
• 13. Dr. Reddy's Laboratories Ltd. (India) III-27
• Table 13: Annual Sales Analysis: 2004-2006 (In INR billion) III-29
• Table 14: Annual Sales Analysis by Segment: 2004-2005 (In INR billion) III-29
• Table 15: Annual Sales Analysis by Geographic Region: 2004-2005 (In INR billion) III-29
• 14. Dragon Pharmaceuticals, Inc. (USA) III-32
• 15. Eli Lilly And Company (USA) III-33
• Table 16: First Quarter Sales Analysis: 2005-2006 (In US$ million) III-34
• Table 17: First Quarter Sales Analysis by Segment: 2005-2006 (In US$ million) III-34
• Table 18: First Quarter Sales Analysis by Product: 2005-2006 (In US$ million) III-35
• Table 19: Annual Sales Analysis: 2003-2005 (In US$ Billion) III-35
• Table 20: Annual Sales Analysis by Segment: 2004-2005 (In US$ million) III-36
• Table 21: Annual Sales Analysis by Product: 2004-2005 (In US$ million) III-36
• Table 22: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million) III-37
• 16. Ferring Pharmaceuticals (USA) III-39
• 17. Gene Medicine Japan, Inc. (Japan) III-40
• 18. GeneMedix PLC (UK) III-41
• 19. Inno Biologics Sdn. Bhd. (Malaysia) III-43
• 20. Insight Biopharmaceuticals Ltd. (Israel) III-44
• 21. Intas Pharmaceuticals Ltd. (India) III-44
• 22. LG Life Sciences (Korea) III-45
• 23. Mayne Pharma PLC (UK) III-46
• 24. Merck KGAA (Germany) III-47
• Table 23: Annual Sales Analysis: 2003-2005 (In € million) III-49
• Table 24: Annual Sales Analysis by Segment: 2004-2005 (In € million) III-49
• 25. Microbix Biosystems, Inc. (Canada) III-53
• Table 25: Half Yearly Sales Analysis: 2005-2006 (H1) (In US$ million) III-53
• Table 26: Annual Sales Analysis: 2004-2005 (In US$ million) III-54
• Table 27: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million) III-54
• 26. Migenix, Inc. (Canada) III-56
• Table 28: Annual Sales Analysis: 2003-2005 (In US$ million) III-56
• Table 29: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million) III-57
• 27. Momenta Pharmaceuticals, Inc. (USA) III-59
• Table 30: First Quarter Sales Analysis:2005-2006 (In US$ million) III-59
• Table 31: Annual Sales Analysis: 2003-2005 (In US$ million) III-60
• 28. Neose Technologies, Inc. (USA) III-61
• Table 32: First Quarter Sales Analysis: 2005-2006 (In US$ million) III-61
• Table 33: Annual Sales Analysis: 2003-2005 (In US$ million) III-62
• Table 34: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million) III-62
• 29. Novartis AG (Switzerland) III-64
• Table 35: First Quarter Sales Analysis: 2005-2006 (In US$ million) III-67
• Table 36: First Quarter Sales Analysis by Segment: 2005-2006 (In US$ million) III-67
• Table 37: Annual Sales Analysis: 2003-2005 (In US$ million) III-68
• Table 38: Annual Sales Analysis by Segment: 2004-2005 (In US$ million) III-68
• Table 39: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million) III-68
• Sandoz International GmbH (Germany) III-77
• Sandoz, Inc. (USA) III-79
• 30. Novo Nordisk A/S (Denmark) III-80
• Table 40: Annual Sales Analysis: 2003-2005 (In DKK million) III-81
• Table 41: Annual Sales Analysis by Segment: 2004-2005 (In DKK million) III-81
• Table 42: Annual Sales Analysis by Geographic Region: 2004-2005 (In DKK million) III-81
• 31. Pfizer, Inc. (USA) III-86
• Table 43: Annual Sales Analysis: 2003-2005 (In US$ billion) III-88
• 32. Pliva D.D. (Croatia) III-95
• Table 44: Annual Sales Analysis: 2003-2005 (In US$ million) III-96
• Table 45: Annual Sales Analysis by Segment: 2004-2005 (In US$ million) III-96
• Table 46: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million) III-96
• 33. Ranbaxy Laboratories Ltd. (India) III-101
• Table 47: First Quarter Sales Analysis: 2004-2005 (In INR billion) III-108
• 34. Savient Pharmaceuticals, Inc. (USA) III-119
• Table 48: First Quarter Sales Analysis: 2005-2006 (In US$ million) III-120
• Table 49: Annual Sales Analysis: 2004-2005 (In US$ million) III-120
• Table 50: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million) III-120
• 35. Shantha Biotechnics Limited (India) III-125
• 36. Shenyang Sunshine Pharmaceutical Co., Ltd. (China) III-127
• 37. Stada Arzneimittel AG (Germany) III-128
• Table 51: Annual Sales Analysis: 2003-2005 (In € million) III-128
• Table 52: Annual Sales Analysis by Segment:2004-2005 (In € million) III-129
• Table 53: Annual Sales Analysis by Geographic Region: 2004-2005 (In € million) III-129
• 38. Teva Pharmaceutical Industries Ltd. (Israel) III-131
• Table 54: First Quarter Sales Analysis: 2005-2006 (In US$ billion) III-132
• Table 55: Annual Sales Analysis: 2003-2005 (In US$ billion) III-133
• Teva Pharmaceuticals (USA) III-141
• Sicor, Inc. (USA) III-141
• 39. Vaccinex, Inc. (USA) III-143
• 40. Wockhardt Ltd. (India) III-144
• Table 56: Annual Sales Analysis: 2003-2005 (In INR billion) III-145
• 41. Zenotech Laboratories Ltd. (India) III-148
• Table 57: Annual Sales Analysis: 2003-2005 (In INR million) III-148
• 42. Zydus Cadila (India) III-149
• Table 58: Annual Sales Analysis: 2004-2005 (In INR million) III-150