Cover Image
市場調查報告書

生技仿製藥:立於新時代入口前的生技仿製藥產業

Biosimilars - Biosimilars on the cusp of a new era

出版商 CBR Pharma Insights 商品編碼 312353
出版日期 內容資訊 英文 58 Pages
商品交期: 最快1-2個工作天內
價格
Back to Top
生技仿製藥:立於新時代入口前的生技仿製藥產業 Biosimilars - Biosimilars on the cusp of a new era
出版日期: 2014年07月31日 內容資訊: 英文 58 Pages
簡介

全球生技仿製藥市場現在,處於迅速變化與發展之中。特別是,Infliximab、Trastuzumab的認證這個動作,預見一個新時代的來臨。為了對應市場迅速的變革,各國的法規當局推進生技仿製藥的開發、認證相關指南的修訂工作,不過各國(特別是美國、歐洲間)的法規標準未完全相符,至今還留存著課題。此外,生技仿製藥的使用疑慮之聲也還殘留著。譬如,從生技仿製藥和首發的生物醫藥品之間,可能產生功效和耐容性差異,在醫生之間也有「生技仿製藥與首發藥類似到什麼程度」、「特別在移植患者的情況,安全性是否有保證」的意見。儘管如此,由於多數的開發中產品存在,及市場參與企業數增加等,全球生技仿製藥市場在今後5年預測將迅速持續成長。特別是,部分大生物醫藥品企業,開發對手企業的生物醫藥品的生技仿製藥版,準備好在市場該層級也能競爭的體制。

本報告提供全球生技仿製藥市場最新趨勢與今後變化的方向性相關分析、圍繞生技仿製藥的最新技術、市場趨勢,及應解決的主要課題、各國政府與監督機關的支援情形、今後的產品開發(臨床實驗)與上市預測等調查、考察。

摘要整理

分析方法

生技仿製藥:概要

  • 生技仿製藥的使用相關主要顧慮事項
  • 自動替代方式
  • 法規環境的變化
  • 歐洲藥品管理局(EMA)的指南
  • 美國食品藥物管理局(FDA)的指南
  • 其他國家的考慮事項

生技仿製藥市場近幾年趨勢

  • 新的生技仿製藥的上市
  • 各國政府/監督機構的見解
  • 對市場的影響

未來展望

  • 生技仿製藥的開發平台
  • 範例變化的可能性
  • 主要企業
  • 產業今後的方向性

附錄

目錄
Product Code: GBI051CBR

The biosimilars market is undergoing rapid change with developments such as the recent approvals of infliximab and trastuzumab heralding a new era. In order to keep up with the pace of change in the marketplace, regulatory agencies have been developing updated guidance around the development and approval of biosimilars, but there is still a lack of consistency, particularly between the two leading agencies - the FDA and EMA.

Moreover, there are some concerns around biosimilar use, for example with physicians worried about how similar certain drugs are and whether they can safely be used in particular patient populations such as transplant, due to the potential for variance in efficacy and tolerability. Despite this, it is expected that the biosimilar market will continue to experience significant growth in the next five to ten years, being driven by the extensive pipeline and the number of companies becoming involved in this area - including some big pharma who are seizing the opportunity to develop biosimilar versions of competitor products in order to ensure they are able to compete at all levels.

Scope

The report covers the following key areas-

  • An overview and background about biosimilars - what they are and a timeline of their development
  • Key concerns regarding the development and use of biosimilars
  • An overview of the issues around automatic substitution with biosimilars
  • The regulatory landscape for biosimilars, including a comparison of FDA and EMA guidelines
  • Recent developments in the biosimilars market including the anticipated patent expiries of key biologic products and launches of new biosimilar products
  • The position of HTA and P&R agencies on biosimilars
  • Industry perspective on the expected impact of biosimilars
  • The biosimilars pipeline and key future developments
  • Key companies involved in biosimilars
  • The way forward for industry

Key Reasons to Purchase

  • The report will Provide an in-depth insight into recent biosimilar regulatory developments including a comparison of the processes used in different markets and the guidance being implemented
  • Assess the biosimilars pipeline including where development is currently focused and the potential impact new biosimilars will have on the marketplace
  • Highlight industry opinions towards biosimilars and their expected impact in different therapy areas and how industry can meet the challenges being presented by biosimilar development and launches
  • Provide an understanding about the key concerns around biosimilar development and use, including manufacturing concerns and issues around automatic substitution
  • Provide an overview of the key companies involved in the biosimilar market including an analysis of where the majority of biosimilar companies are located, the markets in which they operate and the future outlook

Table of Contents

  • Executive summary
  • Methodology
  • Biosimilars: an overview
  • Key concerns surrounding biosimilar use
  • Automatic substitution
  • A changing regulatory landscape
  • EMA guidelines
  • FDA guidelines
  • Considerations for the rest of the world
  • Recent developments in the biosimilars market
  • New biosimilar launches
  • Government/agency opinions
  • Implications for the marketplace
  • The future outlook
  • The biosimilar pipeline
  • Paradigm-changing potential
  • Key players
  • The way forward for industry
  • Appendix
Back to Top