Abstract
Overview
Introduction
Significant barriers to entry into the biosimilars market exist. High up-front investment and the need for specific expertise favor big players. Understanding of the marketplace is critical for success acceptance by key stakeholders is crucial for market uptake of biosimilars and achieving preferential reimbursement status through constant review of the pricing strategy is desirable.
Scope of this report
- In-depth analysis of factors influencing market uptake of biosimilars
- Analysis of the pricing and reimbursement environment for biosimilars
- Detailed analysis of barriers to entry and strategies for success in the biosimilar market
- Overview of strategies for originators' market share protection
Research and analysis highlights
Lack of automatic substitution with biosimilars means that intense promotion strategies need to be employed. Market uptake of biosimilars is highly dependent on acceptance by all key stakeholders especially physicians. All stakeholders need to be informed about biosimilars and various channels can be used.
Payers' reaction to biosimilars is not known, but it is expected they will embrace them after a lag period. Standard incentives used to encourage generics use may not be applicable to biosimilars distributed in hospitals and alternative approaches need to be used.
Barriers to entry remain high: high development and marketing costs compounded with the need for specialist expertise favor big players with strong financial backing and experience in branded generics industry. However smaller specialist players are well positioned to enter this market through co-development and co-marketing agreements.
Key reasons to read this report
Identify key stakeholders than need to be targeted in order to achieve high uptake of biosimilars
Understand the pricing and reimbursement environment of biosimilars, barriers to entry and key strategies for success in the biosimilars market
Gain insight into strategies employed by innovative pharmaceutical and biotechnology companies in order to maintain their market share
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
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