Table of Contents
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the report
- Key findings
- CHAPTER 2 OVERVIEW OF THE BIOSIMILARS MARKET LANDSCAPE
- Who are likely to be the key players in the biosimilar industry?
- Large generics players to be at forefront of biosimilar wave
- Sandoz as the biosimilars pioneer
- Teva to establish itself as a major biosimilar company
- Larger companies pairing up with small specialist biotech
- Branded biologic companies and the biosimilar market
- The fragmented nature of the European market may hinder uptake
- The price of biosimilars
- Will branded manufacturers compete on price?
- Second wave of biosimilars likely to be more profitable
- Confidence in the EMEA' s approval pathway for biosimilars
- Hospital versus retail setting for European biosimilar uptake
- Automatic substitution versus interchangeability
- Potential UK black triangle warning has implications for
interchangeability
- The stakeholder view
- Payers and pharmacists to drive biosimilar uptake
- Physicians must be on board
- Patients unlikely to have a voice on the biosimilar issue
- CHAPTER 3 ISSUES IMPACTING BIOSIMILARS UPTAKE
- Drivers of biosimilar uptake
- Demographic trends point to a need to cut costs
- Some biologic drugs treat rare conditions
- Biologic drug use is on the increase
- High cost of biologics should promote biosimilar uptake
- Rising cost of healthcare in the US and growing use of tier four
- Resistors to biosimilar uptake
- The ' product is the process' dogma will hinder biosimilar uptake
- Biologic drug production can be an issue for both branded and
generic players
- Subtle structural differences in biologic drugs can have clinical
consequences
- Updated black-box warning in US for entire ESA class
- CHMP recommends against epoetin use to treat oncology related anemia
- Heparin contamination issues
- Specialty drug distribution agreements
- CHAPTER 4 US PAYER INSIGHTS
- Were a biosimilar approved, would US payers include it in their
formularies?
- How much clinical data do payers require?
- Stimulation of biosimilar uptake
- Step edits and more favorable reimbursement to promote uptake
- Switching patients from branded to biosimilar drugs is a distinct
possibility
- The level of biosimilar discount
- Rebates as the tool of choice for branded manufacturers
- CHAPTER 5 BIOSIMILAR TEST CASE: HUMAN GROWTH HORMONE
- Testing the water with Omnitrope
- Omnitrope established Sandoz as a key biosimilar player
- The human growth hormone market is difficult to penetrate
- Tev-Tropin' s market presence, prior to Omnitrope launch, may have
contributed to poor uptake in the US
- Branded manufacturers likely to have responded aggressively
- CHAPTER 6 BIOSIMILAR TEST CASE: EPOETIN
- Biosimilar epoetin in Europe, a large lucrative market?
- The epoetin market is a closely held one
- The epoetin market is a difficult one to penetrate, as the experience
of Dynepo shows
- Dynepo made little impact in Europe
- Several biosimilar epoetins have entered the European market
- Biosimilar epoetin makes first showing in cost-conscious Germany
- Physicians guardedly positive about biosimilar epoetin
- Retail sector dominates German epoetin market
- Italian epoetin dispensed in hospital pharmacies
- Biosimilars could struggle in the UK epoetin market
- PASA guarantees price stability, making it difficult for biosimilar
epoetins to enter the market
- Biosimilar epoetin lost a London hospital tender
- Patient resistance is unlikely to sway the decision to switch
- Epoetin buying becoming more centralized, making the retail sector a
better option for biosimilars
- CHAPTER 7 THE FUTURE FOR BIOSIMILARS
- Biosimilar G-CSF market launch imminent
- G-CSF brand choice in Europe
- Biosimilar insulin - a difficult market to enter
- Analogs limit growth opportunities in more developed markets
- US payer stance on biosimilar insulin
- Product loyalty is a factor any insulin biosimilar maker must overcome
- CHAPTER 8 BIBLIOGRAPHY
- Publications and online articles
- Conference literature
- Datamonitor resources
- APPENDIX
- List of Tables
- Table 1: Indian companies manufacturing biosimilars in India, 2008
- Table 2: Epoetin market size in US and 5EU, 2006-07
- Table 3: High cost of biologic drugs in the US, 2008
- Table 4: Estimated savings following the use of biosimilar drugs
- Table 5: Omnitrope sales in the US and 5EU, 2007
- Table 6: Development and marketing of epoetin US and Europe, 2008
- Table 7: Dynepo market share in the US and 5EU, 2007
- Table 8: The retail-hospital split for epoetins in the 5EU, 2007
- List of Figures
- Figure 1: The emerging biosimilar landscape, 2008
- Figure 2: The hospital versus retail divide
- Figure 3: Influence of the key stakeholders in the US and EU to
promote biosimilar uptake, 2008
- Figure 4: Drivers and resistors of biosimilar uptake
- Figure 5: Key stakeholders in the US, and their influence on
biosimilar uptake
- Figure 6: Key drivers and resistors of biosimilar growth hormone uptake
- Figure 7: Price of lyophilized somatropin per gram in Germany and the
US in 2007, relative to that of Omnitrope
- Figure 8: Key drivers and resistors of biosimilar epoetin uptake, 2008
- Figure 9: Epoetin use in the 5EU, 2007
- Figure 10: Effect of biosimilar epoetin on market share in Germany,
September 2006-January 2008
- Figure 11: Hospital epoetin use in the UK, 2008
- Figure 12: Key drivers and resistors of biosimilar granulocyte-colony
stimulating factor (G-CSF) uptake, 2008
- Figure 13: Neulasta versus Neupogen use in the US and Europe, 2003-07
- Figure 14: Granulocyte-colony stimulating factor (G-CSF) use in the
5EU, 2007
- Figure 15: Drivers and resistors for biosimilar insulin uptake, 2008
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