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市场调查报告书
欧洲生物仿制药：技术创新为威胁或是机会
Biosimilar Drugs in Europe: threat or opportunity to innovation?
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欧洲生物仿制药：技术创新为威胁或是机会 是由出版商Doctor's Guide Publishing Limited (FirstWord Pharma)在2011年11月所出版的。
这份英文市场调查报告书包含57 Pages 价格从美金595起跳。
2019年止，众多畅销药将面临专利失效之问题，欧洲将大开生物仿制药门户。而2006年确立之生物仿制药市场预计2015年止，将可达到22亿5,000万～48亿美金规模。
本报告为，汇整欧洲生物仿制药市场现况及开发、制造、许可趋势、新药开发企业地位及保护主义、合作效果等，以下列摘要形式阐述。
实施概要
欧洲中生物仿制药
何谓生物仿制药
- 非专利药及生物仿制药：相似点及不同点
- 欧洲目前可获得之生物仿制药
欧洲生物仿制药之市场机会
- 生物制剂专利失效对市场之影响
- 生物仿制药市场种类于欧洲各国不同
- 生物仿制药于各地区别市场不同
- 义大利处方上具有丰富之品牌药
- 法国、西班牙进行药物之折扣
- 英国于生物仿制药之摄取受到NICE带动
- 德国之生物仿制药依种类不同
- 欧洲生物仿制药之采用依分子及适应症有所不同
- 生物仿制药之采用依慢性疾病治疗及瞬态障碍治疗而不同
- 已确立治疗后，病患对使用生物仿制药产生抗拒
- 医院医师较基层医疗对采用生物仿制药具有弹性
- 生物仿制药影响对费用较敏感之市场
- 小儿科人口对摄入生物仿制药较为消极
欧洲生物仿制药之挑战
- 欧洲之获得许可
- 欧洲生物仿制药之许可流程
- 生物仿制药相关法规沿著陡峭之学习曲线前进
- 法规是否全面公平
- 生物仿制药之挑战：克服开发及制造相关问题
- 生物仿制药之挑战：克服专利问题
- 生物仿制药之挑战：获得利益关系人之信赖
防御姿态：新药开发企业对生物仿制药之摄入有所限制
- 生命周期管理维持市场占有率
- 无法自动替用使新药开发企业受到保护
- 独占性提供及专利使新药开发企业受到保护
- 新药开发企业为维持市场占有率而保持其可信度
- 品质、安全及效果维持其可信度
- 行销、营运、医疗专家训练维持其市场占有率
- 透过相似度保护市场：生物仿制药是否真的相似
- 具竞争力之定价及回扣协议确保较为敏感之客户
攻击姿态：参与新市场
- 定价为生物仿制药之主要差异因素
- 藉由认识市场获得市场占有率
- 信息及教育
- 透过附加价值获得市场占有率：设备、处方
- 透过专利保护生物仿制药
企业环境：生物仿制药企业之机会
生物仿制药市场中之合作及授权
- 非专利药制造商间合作
- 非专利药制造商及新药开发商之合作
- 进入更广泛市场所需之地区性合作
- 生物仿制药之交易数据
- 生物仿制药合约
欧洲生物仿制药之下一步
- 单株抗体急遽参与生物仿制药市场
- 生物改良药将继生物仿制药后出现
- 美国：改革生物仿制药环境
结论
谢辞
参考信息
Abstract
Between now and 2019, a vast range of blockbuster drugs will go off patent,
opening the floodgates in the EU to the biosimilars market. Already
established there since 2006, biosimilars are set to be worth between $2.25
billion and $4.8 billion by 2015.
The potential is undeniable. Yet even in its advanced state compared to other
regulated and unregulated markets, European biosimilars continue to be
challenged by issues and hurdles, ranging from development and manufacturing
to approval and opposition from originator companies. What lessons are there
to be learned?
Report Overview
In Biosimilar Drugs in Europe: Threat or Opportunity to Innovation?,
FirstWord Dossier examines the emerging biosimilars market. The report, based
on expert interviews and analysis, examines market differences across Europe
and different therapeutic areas. The impact of biosimilars on originator
companies - and their response - is discussed, as well as strategies
biosimilar companies will engage in to expand their market share. And most
importantly, the report offers insight into biosimilar deals and what the
future holds in the EU.
Key features
- Discussion of biosimilar markets in five geographic areas
- Examination of key factors driving biosimilar uptake, including molecule
and indications
- Detailed overview of development, manufacturing and approval issues in
Europe
- Insight into the position and protectionism of originator companies
- Reporting on the role of collaboration
Key Benefits
- Access to firsthand opinions from experts in the biosimilars and
biotechnology industry
- Review of deal-making data in biosimilars from a deal-making market leader
- Forward-looking analysis of the future of biosimilars
Key Questions Asked
- What are the challenges facing biosimilars in Europe?
- How can biosimilars companies take market share in Europe?
- How can originator biologics companies keep market share in Europe?
- Which companies are collaborating over biosimilars development?
- What deals are being made?
- What's next for biosimilars?
Who Should Read This Report
- Market access directors and managers
- Medical and scientific affairs professionals
- Pricing and reimbursement teams
- Intellectual property professionals
- Patent analysts
- Legal affairs teams
- Regulatory and government affairs professionals
Expert Views
- Carsten Thiel, Regional Vice President, Europe and Australia, Amgen
- Paul Greenland, EMEA Director of Biosimilars and Proprietary
Marketing at Hospira
- Duncan Emerton, Head of Biosimilars, Datamonitor Healthcare
Consulting
- Asa Cox, Founder of biosimilarlicensing.com
- Lee Coney, Chief Scientific Officer, Biologics, Huntingdon Life
Sciences
- Jim Furniss, Director, Global Market Access Strategy, Bridgehead
International
- Andrew Teuten, Senior Partner, Sagittarius IP
Key Quotes
- "The size of the global biologics market creates a massive opportunity for
biosimilar developers to come in and take some of that market. The size of the
prize in Europe will be significant, so there's a big incentive for biosimilar
companies to come in, develop these biosimilar products, and compete against
the originator brands for market share."
- Duncan Emerton, Head of Biosimilars, Datamonitor Healthcare Consulting
- I can't see the biosimilars market following the classic small molecule
generic model where on day one, five molecules enter the market and the price
drops to 20 percent of the brand. The economics just will not match those of
the small molecule drugs."
- Asa Cox, founder of biosimilarlicensing.com
- "You can see that over time the biosimilar products have started to be
accepted and used quite broadly in certain markets. There is a difference in
uptake between countries - the uptake of biosimilars is not uniform across all
the EU - and there is a difference between individual molecules as well."
-Paul Greenland, EMEA Director of Biosimilars and Proprietary Marketing at
Hospira
Table of Contents
Content Highlights
Executive summary
Biosimilar drugs in Europe
What are biosimilars?
- Generics and biosimilars - similarities and differences
- Biosimilars available so far in Europe
The market opportunities for biosimilars in Europe
- The biologics patent cliff will have an impact on the market
- Market types for biosimilars will differ across Europe
- Geographic markets for biosimilars will vary across Europe
- In Italy, prescriptions are fulfilled by brand
- In France and Spain, drugs are discounted to targets
- In the UK, biosimilar uptake is driven by NICE
- In Germany, biosimilars uptake is good but varies by drug type
- Biosimilar uptake will vary by molecule and indication across Europe
- Epoetin uptake may have been slowed by immunogenicity issues
- Filgrastim uptake has been faster in Europe
- Biosimilar use is likely to vary between chronic and episodic treatment
- There may be a resistance to switching patients on established treatments
- Hospital physicians may be more likely to use biosimilars than primary
care physicians
- Biosimilars will have an impact in cost-sensitive markets
- The paediatric population may be reluctant to take up biosimilars
The challenges for biosimilars in Europe
- The biosimilars challenge: Gaining approval in Europe
- The EU regulatory process for biosimilars
- Biosimilar regulations will be a steep learning curve
- Will regulations be fair and balanced on all points?
- The biosimilars challenge: Overcoming development and manufacturing hurdles
- Biologics are highly variable by nature
- Variations can cause issues with immunogenicity
- The biosimilars challenge: Overcoming patent hurdles
- The biosimilars challenge: Gaining stakeholder trust
- Payers can be a major driver for biosimilars uptake
- Physicians will be key gatekeepers for biologics and biosimilars
- Patients may be cautious about biosimilars
The defensive position: Originator companies will try to limit biosimilar uptake
- Lifecycle management can maintain market share
- Lack of automatic substitution will protect originator drugs
- Exclusivity provisions and patents will protect originator drugs
- Originator companies can exploit loyalty to maintain market share
- Focusing on quality, safety and efficacy claims can maintain loyalty
- Using marketing, sales and healthcare professional training to attract
and keep market share
- Protecting the market through degree of similarity - is a biosimilar
really similar?
- Competitive pricing and rebate agreements will keep cost-sensitive
customers
The offensive position: breaking into a new market
- Pricing is the key differentiator for biosimilars
- Knowing the market will help gain market share
- Information and education: defending biosimilars against the naysayers
- Sales, marketing and account management: Market share through talking to
the payers
- Education for healthcare professionals: Market share through talking to
the physicians
- Gaining market share by adding value: Devices and formulations
- Making the biosimilar easier to use: Devices
- Making the biosimilar easier to handle: formulations
- Protecting biosimilars through patents
The company landscape: Opportunities for companies in biosimilars
- Generics companies will be key players
Collaboration and licensing in the biosimilars market
- Collaborations between generics companies - bringing together development
and marketing
- Collaborations between generic and originator companies combines know-how
and manufacturing capabilities
- Geographic collaborations allows access to wider markets
- Looking into biosimilars deal data
- Biosimilar deals by volume
- Biosimilar deals by value
- Biosimilar deals by type
- Biosimilar deals by indication
- Biosimilar deals: Deal case studies
- Biopharma company signs agreement to access biosimilars
- Generics company signs agreement to fill pipeline
What's next for biosimilars in Europe?
- Monoclonal antibodies will be a dramatic entry to the biosimilars market
- Biobetters could 'follow-on' from biosimilars
- Biobetters will follow a different route of approval
- The US: Changing the biosimilars environment
Conclusion
Acknowledgements
Bibliography
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