Biogenerics 2006: Challenges ahead for an emerging market

Table of Contents

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
• 2.3 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