Biosimilars Series: Strategic issues - Potential remains uncertain

Table of Contents

• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the report
  • Key findings
  • Key definitions
• CHAPTER 2 INTRODUCTION TO THE BIOSIMILARS MARKET
  • Drivers and resistors of growth in the biosimilars market
    • Drivers of biosimilars market growth
      • Biologics market growth
      • Advances in analytical techniques used to characterize biologics
      • Cost-containment pressures are driving the need for biosimilars
    • Resistors of biosimilars market growth
      • Lack of a regulatory pathway in the US
      • Opposition from the innovators
      • Cost and complexity of development
  • Europe as a testing ground
    • Five biosimilars have been approved in Europe so far
  • Outcome of US legislation - market exclusivity and difficulty
• CHAPTER 3 FACTORS INFLUENCING MARKET UPTAKE OF BIOSIMILARS
  • Uptake is critical for market success
    • Patient switching is harder than with small molecule generics
    • Automatic substitution may be governed by legislation
    • Multiple stakeholders need to be targeted to ensure high uptake
      • Pharmacists have a role in the uptake of biosimilars
      • Patients' role in uptake
  • Physician uptake is critical
    • Informing physicians about biosimilars
• CHAPTER 4 PRICING AND REIMBURSEMENT OF BIOSIMILARS
  • Pricing of biosimilars
  • Reimbursement of biosimilars
    • Payers perspective
    • EU payers are influenced by physicians and pharmacists
      • Retail biosimilars can lead to modest savings
      • Standard strategies for promoting generic uptake may not work for biosimilars dispensed in hospitals
    • US payers may introduce reimbursement incentives
      • Tiered formularies are used by MCOs and PBMs
      • MCOs and PBMs are stressing the need for biosimilars
      • Discounts, rebates and patient co-pay will influence the use of biosimilars
  • Product class analysis
    • HGH market is hard to penetrate
    • Price may be the key factor affecting biosimilar epoetin uptake
      • Restrictions on epoetin use in the US will impact the overall market size
      • Launch of first biosimilar epoetin alpha in Europe is imminent
    • Interferon alpha market is dominated by second-generation products
    • Interferon beta market is growing but competition from improved products exists
    • Insulin market is not an attractive target for biosimilars
    • Granulocyte colony-stimulating factor has attracted many biosimilar companies
    • Biosimilar Enbrel presents a very lucrative opportunity
    • Monoclonal antibodies will not be targets for biosimilars in the near future
• CHAPTER 5 BIOSIMILARS MARKET ENTRY
  • Barriers to entry are high but not insurmountable
    • The development of biosimilars is more complex and costly than that of small molecule generics
    • Lack of specific expertise
    • Complex patent protection of biologics is another barrier
    • High promotional costs
    • Expensive to exit
  • Competitive landscape less crowded than for small molecule drug generics
    • Smaller number of entrants
    • Early entry brings advantage but is risky
    • Contract manufacturing organizations will enter the biosimilars market
    • Big players will remain
    • Biosimilars manufacturers in the emerging markets
      • Low cost base is an advantage...
      • ...but gaining regulatory approval is difficult
      • Confidence is important for acceptance
  • Case Study: Omnitrope - the story so far
    • Omnitrope' s EU approval was not smooth
    • US approval for Omnitrope was granted only after a law suit
    • Pricing and launch strategy for Omnitrope
    • Omnitrope' s branding strategy
    • Omnitrope sales to date
    • Line extension - liquid Omnitrope formulation
  • Case Study: Sandoz' s biosimilar epoetin alpha
• CHAPTER 6 KEY RECOMMENDATIONS FOR SUCCESS
  • Making biosimilar products
    • Acquire biopharmaceutical expertise, facilities or pipelines
  • Marketing of biosimilar products
  • Achieving profitability in the biosimilars market
    • Low-cost manufacturing
    • Choice of reference product is important
    • Early entrants are rewarded
    • Enter strategic partnerships
  • Positioning of biosimilars - biosimilar or full submission route
  • Second-generation biosimilars
  • SWOT analysis of biosimilars manufacturers
• CHAPTER 7 ORIGINATORS' STRATEGIES FOR MARKET SHARE PROTECTION
  • Communication with decision makers is crucial
    • Lobbying regulatory bodies
      • Automatic substitution should not be allowed for biosimilars
      • Labels should clearly state if a product is a biosimilar
      • Biosimilars should have different names
    • Informing physicians and patients about proven safety
    • Informing payers about quality and cost of service
  • Patent protection
  • Pricing strategies
  • Lifecycle management strategies for biologics
    • Authorized biosimilars
    • Licensing agreements with biosimilar manufacturers
    • Line extension
    • Innovative delivery systems
  • Innovation, innovation, innovation
  • Will branded pharma and biotech enter the biosimilars market?
• CHAPTER 8 BIBLIOGRAPHY
  • Publications and online articles
  • Conference literature
  • Datamonitor resources
  • Suggested reading
• GLOSSARY
  • List of Tables
    • Table 1: Aspects of biosimilars that influence acceptance by pharmacists
    • Table 2: Companies taking part in the South London epoetin tender
    • Table 3: Development and approval processes of biosimilars and small molecule generics
    • Table 4: Omnitrope sales by country, H2 2006-H1 2007 in USD
  • List of Figures
    • Figure 1: Multiple stakeholders need to be targeted
    • Figure 2: Stakeholder influence on the final dispensing decision depends on the setting
    • Figure 3: Adoption process is different for hospital and retail biosimilars
    • Figure 4: Tiered formularies are used in the US
    • Figure 5: Competencies required for the development and marketing of biosimilars
    • Figure 6: Barriers to biosimilars market entry
    • Figure 7: Biosimilars development and marketing is a long and costly process
    • Figure 8: Key challenges and strategies for success in the biosimilars market
    • Figure 9: The 4Ps of marketing biosimilars
    • Figure 10: Characteristics of a successful biosimilars company
    • Figure 11: SWOT analysis of biosimilars manufacturers