Abstract
Overview
Introduction
Although Europe is leading the way, the biosimilar industry is very much in
its infancy, with the perception of key decision makers critical to the
initial rate of uptake. The opinion of key stakeholders, and the influence
they wield, will therefore inform the strategy of both the branded and
biosimilar contingents, in what is likely to become a battle to gain trust.
Scope
An overview of the key drivers and resistors to biosimilar use. An outline of
the key stakeholders in Europe and the US, and relative influence they have.
An insight into the opinion of payers, physicians and hospital pharmacists,
regarding biosimilar use. An understanding of how the industry will develop,
and the strategies to be employed by the pro and anti biosimilar factions.
Highlights
Biologics use is set to grow, at a rate that far outstrips that of small
molecule drugs. The considerably greater cost of biologics will therefore
combine with increased utilization to put payers under pressure to promote
biosimilar use.
Due to the complexity of biologic drugs, there are greater concerns regarding
biosimilar safety and efficacy compared with standard generics, which are
likely to only be alleviated following time on the market. Consequently,
initial uptake will be greatly influenced by the perceptions of key
stakeholders.
The opinion of physicians is considered important by both branded and
biosimilar companies, and in Europe this group currently holds the most power.
Although motivated to promote generics, payers and pharmacists to an extent,
often defer to physicians in Europe, although there is evidence this is not
the case in the US.
Reasons to Purchase
- Understand which drugs are subject to biosimilar erosion in Europe now,
and going forward.
- Understand who the key stakeholders are and the influence they have on
biosimilar uptake.
- Gain an insight into how the biosimilar industry will develop, and the
strategies companies will employ to promote or resist uptake.
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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