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市場調查報告書
歐洲生物仿製藥：技術創新為威脅或是機會
Biosimilar Drugs in Europe: threat or opportunity to innovation?
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歐洲生物仿製藥：技術創新為威脅或是機會 是由出版商Doctor's Guide Publishing Limited (FirstWord Pharma)在2011年11月所出版的。
這份英文市場調查報告書包含57 Pages 價格從美金595起跳。
2019年止，眾多暢銷藥將面臨專利失效之問題，歐洲將大開生物仿製藥門戶。而2006年確立之生物仿製藥市場預計2015年止，將可達到22億5,000萬∼48億美金規模。
本報告為，匯整歐洲生物仿製藥市場現況及開發、製造、許可趨勢、新藥開發企業地位及保護主義、合作效果等，以下列摘要形式闡述。
實施概要
歐洲中生物仿製藥
何謂生物仿製藥
- 非專利藥及生物仿製藥：相似點及不同點
- 歐洲目前可獲得之生物仿製藥
歐洲生物仿製藥之市場機會
- 生物製劑專利失效對市場之影響
- 生物仿製藥市場種類於歐洲各國不同
- 生物仿製藥於各地區別市場不同
- 義大利處方上具有豐富之品牌藥
- 法國、西班牙進行藥物之折扣
- 英國於生物仿製藥之攝取受到NICE帶動
- 德國之生物仿製藥依種類不同
- 歐洲生物仿製藥之採用依分子及適應症有所不同
- 生物仿製藥之採用依慢性疾病治療及瞬態障礙治療而不同
- 已確立治療後，病患對使用生物仿製藥產生抗拒
- 醫院醫師較基層醫療對採用生物仿製藥具有彈性
- 生物仿製藥影響對費用較敏感之市場
- 小兒科人口對攝入生物仿製藥較為消極
歐洲生物仿製藥之挑戰
- 歐洲之獲得許可
- 歐洲生物仿製藥之許可流程
- 生物仿製藥相關法規沿著陡峭之學習曲線前進
- 法規是否全面公平
- 生物仿製藥之挑戰：克服開發及製造相關問題
- 生物仿製藥之挑戰：克服專利問題
- 生物仿製藥之挑戰：獲得利益關係人之信賴
防禦姿態：新藥開發企業對生物仿製藥之攝入有所限制
- 生命週期管理維持市場佔有率
- 無法自動替用使新藥開發企業受到保護
- 獨占性提供及專利使新藥開發企業受到保護
- 新藥開發企業為維持市場佔有率而保持其可信度
- 品質、安全及效果維持其可信度
- 行銷、營運、醫療專家訓練維持其市場佔有率
- 透過相似度保護市場：生物仿製藥是否真的相似
- 具競爭力之定價及回扣協議確保較為敏感之客戶
攻擊姿態：參與新市場
- 定價為生物仿製藥之主要差異因素
- 藉由認識市場獲得市場佔有率
- 資訊及教育
- 透過附加價值獲得市場佔有率：設備、處方
- 透過專利保護生物仿製藥
企業環境：生物仿製藥企業之機會
生物仿製藥市場中之合作及授權
- 非專利藥製造商間合作
- 非專利藥製造商及新藥開發商之合作
- 進入更廣泛市場所需之地區性合作
- 生物仿製藥之交易數據
- 生物仿製藥合約
歐洲生物仿製藥之下一步
- 單株抗體急遽參與生物仿製藥市場
- 生物改良藥將繼生物仿製藥後出現
- 美國：改革生物仿製藥環境
結論
謝辭
參考資訊
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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