Biosimilars Series: Strategic issues - Potential remains uncertain
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- CHAPTER 1 EXECUTIVE SUMMARY - page 4
- Scope of the report - page 4
- Key findings - page 4
- Key definitions - page 7
- CHAPTER 2 INTRODUCTION TO THE BIOSIMILARS MARKET - page 11
- Drivers and resistors of growth in the biosimilars market - page 11
- Drivers of biosimilars market growth - page 11
- Biologics market growth - page 11
- Advances in analytical techniques used to characterize biologics - page 12
- Cost-containment pressures are driving the need for biosimilars - page 12
- Resistors of biosimilars market growth - page 12
- Lack of a regulatory pathway in the US - page 12
- Opposition from the innovators - page 14
- Cost and complexity of development - page 14
- Drivers of biosimilars market growth - page 11
- Europe as a testing ground - page 14
- Five biosimilars have been approved in Europe so far - page 15
- Outcome of US legislation - market exclusivity and difficulty - page 15
- Drivers and resistors of growth in the biosimilars market - page 11
- CHAPTER 3 FACTORS INFLUENCING MARKET UPTAKE OF BIOSIMILARS - page 17
- Uptake is critical for market success - page 17
- Patient switching is harder than with small molecule generics - page 17
- Automatic substitution may be governed by legislation - page 18
- Multiple stakeholders need to be targeted to ensure high uptake - page 19
- Pharmacists have a role in the uptake of biosimilars - page 24
- Patients' role in uptake - page 28
- Physician uptake is critical - page 30
- Informing physicians about biosimilars - page 31
- Uptake is critical for market success - page 17
- CHAPTER 4 PRICING AND REIMBURSEMENT OF BIOSIMILARS - page 33
- Pricing of biosimilars - page 33
- Reimbursement of biosimilars - page 35
- Payers perspective - page 35
- EU payers are influenced by physicians and pharmacists - page 36
- Retail biosimilars can lead to modest savings - page 36
- Standard strategies for promoting generic uptake may not work for biosimilars dispensed in hospitals - page 37
- US payers may introduce reimbursement incentives - page 40
- Tiered formularies are used by MCOs and PBMs - page 40
- MCOs and PBMs are stressing the need for biosimilars - page 41
- Discounts, rebates and patient co-pay will influence the use of biosimilars - page 42
- Product class analysis - page 44
- HGH market is hard to penetrate - page 44
- Price may be the key factor affecting biosimilar epoetin uptake - page 45
- Restrictions on epoetin use in the US will impact the overall market size - page 47
- Launch of first biosimilar epoetin alpha in Europe is imminent - page 47
- Interferon alpha market is dominated by second-generation products - page 48
- Interferon beta market is growing but competition from improved products exists - page 49
- Insulin market is not an attractive target for biosimilars - page 50
- Granulocyte colony-stimulating factor has attracted many biosimilar companies - page 51
- Biosimilar Enbrel presents a very lucrative opportunity - page 52
- Monoclonal antibodies will not be targets for biosimilars in the near future - page 52
- CHAPTER 5 BIOSIMILARS MARKET ENTRY - page 54
- Barriers to entry are high but not insurmountable - page 54
- The development of biosimilars is more complex and costly than that of small molecule generics - page 55
- Lack of specific expertise - page 58
- Complex patent protection of biologics is another barrier - page 59
- High promotional costs - page 59
- Expensive to exit - page 60
- Competitive landscape less crowded than for small molecule drug generics - page 61
- Smaller number of entrants - page 61
- Early entry brings advantage but is risky - page 61
- Contract manufacturing organizations will enter the biosimilars market - page 63
- Big players will remain - page 63
- Biosimilars manufacturers in the emerging markets - page 64
- Low cost base is an advantage... - page 65
- ...but gaining regulatory approval is difficult - page 66
- Confidence is important for acceptance - page 66
- Case Study: Omnitrope - the story so far - page 67
- Omnitrope's EU approval was not smooth - page 67
- US approval for Omnitrope was granted only after a law suit - page 67
- Pricing and launch strategy for Omnitrope - page 68
- Omnitrope's branding strategy - page 68
- Omnitrope sales to date - page 69
- Line extension - liquid Omnitrope formulation - page 70
- Case Study: Sandoz's biosimilar epoetin alpha - page 70
- Barriers to entry are high but not insurmountable - page 54
- CHAPTER 6 KEY RECOMMENDATIONS FOR SUCCESS - page 72
- Making biosimilar products - page 73
- Acquire biopharmaceutical expertise, facilities or pipelines - page 73
- Marketing of biosimilar products - page 74
- Achieving profitability in the biosimilars market - page 77
- Low-cost manufacturing - page 77
- Choice of reference product is important - page 78
- Early entrants are rewarded - page 78
- Enter strategic partnerships - page 79
- Positioning of biosimilars - biosimilar or full submission route - page 80
- Second-generation biosimilars - page 81
- SWOT analysis of biosimilars manufacturers - page 82
- Making biosimilar products - page 73
- CHAPTER 7 ORIGINATORS' STRATEGIES FOR MARKET SHARE PROTECTION - page 83
- Communication with decision makers is crucial - page 83
- Lobbying regulatory bodies - page 83
- Automatic substitution should not be allowed for biosimilars - page 84
- Labels should clearly state if a product is a biosimilar - page 85
- Biosimilars should have different names - page 85
- Informing physicians and patients about proven safety - page 86
- Informing payers about quality and cost of service - page 87
- Lobbying regulatory bodies - page 83
- Patent protection - page 87
- Pricing strategies - page 88
- Lifecycle management strategies for biologics - page 89
- Authorized biosimilars - page 89
- Licensing agreements with biosimilar manufacturers - page 90
- Line extension - page 90
- Innovative delivery systems - page 91
- Innovation, innovation, innovation - page 91
- Will branded pharma and biotech enter the biosimilars market? - page 92
- Communication with decision makers is crucial - page 83
- CHAPTER 8 BIBLIOGRAPHY - page 94
- Publications and online articles - page 94
- Conference literature - page 97
- Datamonitor resources - page 97
- Suggested reading - page 98
- GLOSSARY - page 99
- List of Tables
- Table 1: Aspects of biosimilars that influence acceptance by pharmacists - page 26
- Table 2: Companies taking part in the South London epoetin tender - page 39
- Table 3: Development and approval processes of biosimilars and small molecule generics - page 56
- Table 4: Omnitrope sales by country, H2 2006-H1 2007 in USD - page 69
- List of Figures
- Figure 1: Multiple stakeholders need to be targeted - page 20
- Figure 2: Stakeholder influence on the final dispensing decision depends on the setting - page 22
- Figure 3: Adoption process is different for hospital and retail biosimilars - page 23
- Figure 4: Tiered formularies are used in the US - page 41
- Figure 5: Competencies required for the development and marketing of biosimilars - page 54
- Figure 6: Barriers to biosimilars market entry - page 55
- Figure 7: Biosimilars development and marketing is a long and costly process - page 56
- Figure 8: Key challenges and strategies for success in the biosimilars market - page 72
- Figure 9: The 4Ps of marketing biosimilars - page 75
- Figure 10: Characteristics of a successful biosimilars company - page 79
- Figure 11: SWOT analysis of biosimilars manufacturers - page 82
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