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生技仿製藥:歐洲的保險用戶 (Payer) 展望 (2016年)

Biosimilars: European Payer Perspectives (2016)

出版商 FirstWord 商品編碼 326352
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
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生技仿製藥:歐洲的保險用戶 (Payer) 展望 (2016年) Biosimilars: European Payer Perspectives (2016)
出版日期: 2016年01月01日 內容資訊: 英文




  • 高價值的開發中管道
    • 生技仿製藥開發的品牌藥
    • 如何使用、將如何變化?
  • 互換性
    • 何時何地可將生技仿製藥與品牌藥互換?
  • 適應症外推
    • 如何應對已被承認的適應症問題
  • 現實資料
    • 臨床上的數據可被經驗提升、現實世界資料是否可用於所有治療領域?該如何獎勵?
  • 進一步的教育
    • 醫師的教育不足 (特別是適應症外推) 阻礙了引進
    • 生技仿製藥產業該如何應對?
  • 處方集的追加
    • 處方集追加的基準?
    • 價格重要度?
    • 上市的所有生技仿製藥空間
  • 藥價設定
    • 怎樣是生技仿製藥最佳折扣?
    • 未來品牌藥與生技仿製藥價格標竿?
  • 目標、配額
    • 處方目標、配額將如何用來促進歐洲各國的生技仿製藥?
    • 成功機率?


Product Code: 596200479

What's driving the uptake of biosimilars in Europe and what still needs to be done?

The European market for biosimilars has seen a year of progress and change , with more therapies available and changing attitudes from many payers . Driven by the pressing need to control drug costs, payers have notably moved their position in key areas such as interchangeabilty and indication extrapolation. But where are the sticking points? What are the critical factors for success? What more could the biosimilar industry do to help its cause?

This report identifies the issues that payers identify as critical to the continued growth and adoption of biosimilars. Biosimilars: European Payer Perspectives is informed with candid insights of 15 European payers from the five leading European markets and packed with actionable information. It is essential reading for all commercial and research planners in branded and biosimilar manufacturers .

"The key reimbursement challenge at the moment comes down to the four-letter word of cost: every healthcare organisation is really struggling to contain cost."

Answering Key Questions

  • High value pipeline : What are the leading branded therapies that are in biosimilar development and how will their availability continue to drive change?
  • Interchangeability : When, and in what circumstances, could a biosimilar be interchangeable with the branded product?
  • Indication extrapolation : What can be done to challenge the lingering anxieties that are impacting the broader use of biosimilars across all approved indications?
  • Real world data : Clinical confidence is growing with experience but can real world data encourage wider adoption across all therapy areas and who should collect/disseminate it?
  • Better education : A lack of physician education, especially in areas such indication extrapolation, is limiting uptake - how can the biosimilar industry positively respond?
  • Formulary inclusion : What are the differing criteria for formulary inclusion, to what extent does price play a role and is there room for every biosimilar that comes to market?
  • Pricing : What level of biosimilar discounting is optimal and will we ever see price matching between branded and biosimilar products?
  • Targets and Quotas : To what extent have prescribing targets and quotas driven biosimilar usage in European countries and are they always successful?

With this report you will be able to:

  • Learn from the experiences of EU payers and the critical factors they identify as essential for biosimilar market progress
  • Understand how issues and questions around interchangeability, switching and indication extrapolation are limiting broader biosimilar usage
  • Identify the key areas where better physician education could have real benefits and formulate appropriate communication strategies
  • Examine how clinical and real world data can help build prescriber and payer confidence
  • Understand current EU biosimilar regulation and guidance and know where payers feel improvements could be made
  • Know the key elements for successful biosimilar formulary inclusion
  • Explore payer thinking on pricing, discounts, reimbursement and prescribing targets/quotas

Key Topics explored

  • How confidence in the sector is growing as a result of more biosimilar products now being on the market, and the increasing number of blockbuster therapies becoming the subject of biosimilar research
  • The challenge of convincing physicians, especially those with limited experience, to prescribe biosimilars
  • The EU regulation of biosimilars is seen by many as the best system, but there is still room for improvement
  • Biosimilars benefit from an abridged regulatory process, but that can lead to questions about safety in all patient populations - is it time for a rethink and how might real world data fill the knowledge gap?
  • It is alleged that mis information from branded industry and other stakeholders is feeding physician anxiety. True or false?
  • Why are patient advocacy groups less than enthusiastic about biosimilars and what impact is this having on biosimilar uptake?
  • The naming of biosimilars in the EU is causing confusion: is there a viable and universally agreeable alternative on the horizon?

Expert Contributors

For this report FirstWord has interviewed 15 payers, 3 from each EU5 country. Payers interviewed have direct experience of assessing biosimilars for inclusion on formulary, either as part of a committee or as the lead decision-maker.

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