1.
Executive Summary
1.1 Aims of this Report
1.2 Chapter Summaries
2.
Introduction
2.1 Brief Background of Biotech Drugs
2.1.1 Commonly Used Terminology
2.1.2 Summary of Recombinant DNA Technology
2.1.3 Classes of Biotech Drugs
2.2 Biotech Drugs Are Increasing in Importance
2.2.1 Biopharmaceuticals Are Versatile Agents
2.2.2 Biopharmaceuticals Share 12.5% of 2004 Global Prescriptions
2.2.3 In 2004 the Biopharmaceuticals Market Was Worth $55.7bn
2.2.4 Monoclonal Antibodies: Leading Class of Biopharmaceuticals in 2004 With Sales of $13bn
2.2.5 In 2004 Biotech Drugs Were Worth Over 10% of the World Pharma Market
2.2.6 Biotech Pipelines are Growing
2.2.5 In 2004 Biotech Drugs Were Worth Over 10% of the World Market for Drugs
2.2.6 Biotech Pipelines Are Growing
2.3 The Success of Generics
2.3.1 The Hatch-Waxman Act in the US
2.3.2 Governments Look to Generics to Cut Healthcare
Costs
2.4 The Emergence of Biogenerics
2.4.1 The Failure of Hatch-Waxman for Biologicals
2.4.2 Patent Expiry for Key Biotech Drugs
2.4.3 Lack of Regulatory Guidelines Delays the Growth of Biogenerics
2.4.4 Names Are Important
3.
Drivers and Restraints
3.1 SWOT Analysis
3.2 Healthcare Costs Are Rising and Biotech Drugs Are a Large Part of these Costs
3.3 Major Markets Accept Generic Replacements
3.4 Improved Technology Has Strengthened the Case for Biogenerics
3.5 Large Generic Companies Have the Resources to Develop Biogenerics
3.6 High Revenues Will Encourage the Development of Biogenerics
3.7 Asian Pharmaceutical Markets Display High Growth
3.8 Bioequivalence Will Remain Difficult to Demonstrate
3.9 Biotech Drugs Are Expensive to Develop
3.10 Biotech Drugs Often Target Niche Markets
3.11 Regulators and Patients Are Cautious Over Safety
3.11.1 Adverse Events Connected to Branded Biotech Drugs Will Disproportionately Affect Biogenerics
3.12 The Next Generation of Biotech Drugs Will Restrain Growth in Biogenerics
3.13 The Key Question for Biogenerics - How Innovative Do You Need to Be?
4.
Biogeneric Regulations
4.1 The FDA Has No Procedure for Biogenerics
4.1.1 The Generics Industry Desperately Needs a Ruling on Biogenerics
4.1.2 Omnitrope - A Test Case?
4.1.3 The Omnitrope Case Proves That Section 505(b)(2) is Insufficient
4.2 The EMEA Leads the Way
4.2.1 Guidelines Are Released on a Case-by-case Basis
4.3 The Future of Biogeneric Legislation
4.3.1 The EU is Ahead But the FDA Will Catch Up
4.3.2 The Right Communication Strategy is Vital
4.3.3 Insulin, Growth Hormones and Other Simple Proteins Will Benefit From Relaxed Regulations
4.3.4 Lack of Commercial Appreciation May Inhibit Biogeneric Growth
5.
Using Technology to Demonstrate Bioequivalence
5.1 General Approach to Regulatory Approval of Biogenerics
5.1.1 Consult with the Regulatory Authorities Often
5.1.2 Simple Methods May Be Best
5.1.3 Structure/Function Relationship Is the Key to Reducing the Requirement for Clinical Trials
5.2 A Summary of Available Techniques
5.2.1 Defining Primary Structure
5.2.2 Defining Secondary/Tertiary Structure
5.2.3 An Orthogonal Comparative Approach Can Compensate for Conclusive Structural Data
5.3 Specific Considerations
5.3.1 Different Glycosylation States
5.3.2 Immunogenicity
6.
Possible Biogeneric Drugs
6.1 The Complexity of Biogenerics Varies
6.1.1 Patents for Biotech Drugs Are Complicated But Should Not Be Taken for Granted
6.1.2 Complexity Will Ultimately Define the Success of Biogenerics and Not Patent Loss
6.2 Insulins 6.2.1 Innovation Has Produced a Range of Insulin Products
6.2.2 Insulin is Off-patent But Key Patents Remain
6.2.3 Generic Insulins Will Be Amongst the First Biogenerics But Will Not Claim High Market Share
6.3 Human Growth Hormone (Somatropin)
6.3.1 The Human Growth Hormone Market Has a Large Number of Similar Products
6.3.2 Genotropin Leads the Somatropin Market
6.3.3 The Biogeneric hGH Market Will Grow But Competition Will Restrict this Growth
6.4 Epoetin Alpha
6.4.1 Epoetin Products Have Been Successful
6.4.2 The Patent for Epoetin Alpha Has Expired
6.4.3 The Regulatory Authorities Will Require Extensive Data for EPO
6.5 Interferons
6.5.1 Many Interferon Drugs Have Lost Patent Protection
6.5.2 The Interferon Market Is Growing
6.5.3 Interferons Are Going to Face High Competition from Biogenerics
6.6 Other Possible Targets for Biogenerics
6.6.1 Neupogen Sales Are Maintained Despite the Introduction of Neulasta
6.6.2 NovoSeven
7.
Opinions and Strategies for Biogenerics
7.1 Pharmaceutical/Biotech Industry
7.1.1 Branded Companies See Biotech as Solution to Generic Erosion
7.1.2 Lobbying Against Biogenerics Has Been Successful So Far
7.1.3 Smart Lifecycle Management Is Key
7.1.4 Cost Cuts Will Play a Major Role in the Future
7.1.5 Could Big Pharma Venture into Biogenerics?
7.2 Generics Industry
7.2.1 The Generics Industry Needs to Win the Process Vs Product Debate
7.2.2 The Generics Industry Believes that the Right Technology Is Available
7.2.3 Brand Recognition is Important for Biogenerics
7.2.4 Are Transgenics the Answer to Cost Pressures?
7.3 Patients' Views Are Often Ignored
7.3.1 Complicated Treatments Result in Well Informed, Opinionated Patients
7.3.2 Patients Do Not Believe It Is a Straight Switch
7.3.3 Pharmacovigilance Is the Key to Persuading Patients
8.
Biogenerics in India and China
8.1 Chinese and Indian Pharmaceutical Industries Are Growing in Importance
8.2 Both Markets Have a High Demand for Low Cost Biologicals
8.3 Lack of Regulations Have Allowed the Biotech Industry to Flourish
8.4 India Has Vast Experience of Biotechnology
8.4.1 India Has the Advantage of FDA-recognised Sites and Global Companies
8.4.2 There Are Biogenerics on the Indian Market and More in the Pipeline
8.4.3 Growth of Clinical Trials Industry Means Faster Development
8.5 China
8.5.1 There Is High Government Investment in the Biotech Industry
8.5.2 Lack of Global Presence Will Restrict the Chinese Biogenerics Industry
8.5.3 Weak International Patent Protection Remains an Obstacle
8.6 Asian Companies Will Play a Major Role in the Biogenerics Industry But Global Companies Will Not Be Left Behind
9.
Leading Biogeneric Companies
9.1 Global Generics Companies Venture into Biogenerics
9.1.1 Teva Has the Resources and the Expertise to Succeed
9.1.2 Sandoz Can Build on its Biotech Experience
9.1.3 Pliva
9.2 Smaller Biotech Companies Specialising in Biogenerics
9.2.1 BioPartners
9.2.2 Cangene
9.2.3 GeneMedix
9.2.4 Bioceuticals (Stada)
9.2.5 BioGenerix (Ratiopharm)
9.3 Asian Companies Seek to Expand into Lucrative Markets
9.3.1 Dr Reddy's Laboratories
9.3.2 Wockhardt
9.3.3 Dragon Pharmaceuticals
9.4 Companies Are Concentrating on the Low Hanging Fruit
10.
Conclusion: Biogenerics Have Arrived
10.1 EU Guidelines Will Help Create a Worldwide Biogenerics Market
10.2 Careful Attention to Detail Is Essential for Biogeneric Submissions
10.3 Case-by-case Assessment Will Limit Growth But Build Confidence
10.4 Complexity is Key - Generic MAbs Will Have to Wait
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