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市場調查報告書 - 229431


Canada: Generics and Biosimilars Overview

出版商 Datamonitor
出版日期 內容資訊 英文 36 Pages
加拿大:學名藥和生技仿製藥概要 Canada: Generics and Biosimilars Overview
出版日期: 2011年11月03日 內容資訊: 英文 36 Pages

加拿大的非專利藥品市場儘管在各州的市場競爭的策略實施和對小規模非專利藥品·營運商的進一步機會的提供,仍面臨大量的課題。 關於被稱為生技仿製藥的SEB,2010年3月加拿大衛生署公佈SEB核准的法規指南。


第1章 執行摘要

  • 簡介
  • 策略性調查範圍和焦點
  • Datamonitor的主要報告
    • 非專利藥品市場
    • 生技仿製藥市場
  • 相關報告

第2章 加拿大:非專利藥品市場概要

  • 非專利藥品市場動態
    • 學名藥的出貨量
    • 學名藥的銷售額
    • 非專利藥品市場規模
  • 學名藥的發展/阻礙因素
    • IP法的強化預計將虧損2.8億美元的儲蓄
    • 學名藥的新興市場出口成長的準備
    • 藥店回扣協議與學名藥的漲價和大營運商以外的排除有關
    • 加拿大的數州的降價進一步對收益造成影響
    • 自動替換獲得在一部分的州/領域的核准
    • 促進學名藥引進的協調政策與成本削減相關
  • 主要非專利藥品·營運商
    • Apotex在對美國的出口中面臨困難
    • Teva擴大加拿大產業
    • Sandoz
  • 非專利藥品產業的機會

第3章 生技仿製藥市場概要

  • SEB核准途徑的公佈
    • 加拿大的SEB核准途徑的主要必要條件
    • 六年的數據獨佔
    • 主要市場與生技仿製藥的指南的比較
  • SEB引進的發展因素
    • Omnitrope的加拿大的核准
    • SEB核准從加拿大幾個適應症預期估計
    • SEB的替代受到聯邦機構的阻礙
  • 市售/開發平台的SEB
    • Omnitrope為加拿大市售唯一的SEB
    • 加拿大市場開發中的SEB
    • SEB產業的機會
  • 主要SEB營運商
    • Sandoz
    • 鎖定進入加拿大SEB市場的企業

第4章 參考文獻

  • 出版物和網路文章
  • Datamonitor的報告與產品

第5章 附錄




The Canadian generics market faces a number of challenges, although provinces are now implementing strategies to increase competition in the market, and provide greater opportunities for smaller generics players. In terms of biosimilars, referred to as subsequent entry biologics (SEBs), Health Canada in March 2010 published its regulatory guidance for the approval of SEBs.

Features and benefits

  • Compares the Canadian generics market in terms of value and volume to other leading developed and emerging markets.
  • Insight into the key drivers and resistors to generics uptake in Canada, and identifies key small molecule brands set to face patent expiry.
  • Assess the key requirements of the Canadian subsequent entry biologics (SEB) approval pathway.
  • Analyses biosimilar uptake in Canada and provides insight into the future opportunities for biosimilar players.


  • The Canadian generics market is facing a number of challenges with strengthening intellectual property laws threatening to delay market entry, while several provinces have also introduced price cuts.
  • Ontario banned pharmacist rebates in April 2010 in a move which should restore a greater level of competition in the market, and provide greater opportunities for smaller generics players. Furthermore, harmonization of provincial generic regulations would improve generic uptake and reduce bureaucracy and confusion for generics companies.
  • While the SEB market is in its infancy with Omnitrope (somatropin; Sandoz) the only product currently available, it is expected that the introduction of the SEB approval pathway will lead to further SEBs entering the market in the near future.

Your key questions answered

  • Evaluate the evolving regulatory environments for generics and biosimilars/SEBs in Canada, and how this impacts market access and uptake.
  • Identify the leading players and future biosimilar/SEB and generic opportunities in Canada.


Executive Summary

  • Introduction
  • Canada - Strategic scoping and focus
  • Canada - Datamonitor key findings
    • Generics market
    • Biosimilars market
  • Related reports


  • Canada - Generics market dynamics
    • Canada generics volume uptake
    • Canada generics value uptake
    • Canada generics market size
  • Canada - Generics drivers and resistors
    • Strengthening IP laws could cost Canada $2.8bn in lost savings
    • Generic exports to emerging markets set to increase
    • Pharmacist rebate agreements lead to high generics prices and exclude all but the biggest players
    • Price cuts in several Canadian provinces have further impacted profitability
    • Automatic substitution is allowed in some provinces/territories
    • A harmonized policy to promote generic uptake could lead to cost savings
  • Canada - Key generics players
    • Apotex faces difficulties in exports to the US
    • Teva expands operations in Canada
    • Sandoz
  • Canada - Opportunities for the generics industry


  • Canada - Roll out of the SEB approval pathway
    • Key requirements of the Canadian SEB approval pathway
    • Data exclusivity is 6 years in Canada
    • Comparison of biosimilars guidelines across major markets
  • Canada - Drivers of SEB uptake
    • Omnitrope is approved in Canada
    • SEB approval may be extrapolated across multiple indications in Canada
    • Substitution of SEBs discouraged by federal authorities
  • Canada - Marketed and pipeline SEBs
    • Omnitrope is the only SEB marketed in Canada
    • SEBs in development for the Canadian market
    • Opportunities for the SEB industry
  • Canada - Key SEB players
    • Sandoz
    • Companies looking to enter the Canadian SEB market


  • Publications and online articles
  • Datamonitor reports and products


  • Exchange rates used in this report
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