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市場調查報告書

生技仿製藥:法律規章上的架構和開發平台分析

BIOSIMILARS - Regulatory Framework and Pipeline Analysis

出版商 CBR Pharma Insights 商品編碼 334084
出版日期 內容資訊 英文 94 Pages
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生技仿製藥:法律規章上的架構和開發平台分析 BIOSIMILARS - Regulatory Framework and Pipeline Analysis
出版日期: 2015年06月01日 內容資訊: 英文 94 Pages
簡介

本報告提供生技仿製藥的開發策略上必要的法律規章上的要件及各地區、主要國家架構調查、推動市場成長的要素與阻礙要素、開發中的藥物狀況與開發階段、分子、治療區域、適應症等各種參數詳細內容、主要的進入經營者簡介等彙整。

目錄

  • 摘要整理
  • 簡介
  • 生技仿製藥產業的動態
    • 趨勢
    • 成長推進因素
    • 阻礙成長要素
  • 生技仿製藥的法律規章:WHO指導
  • 歐洲的生技仿製藥
    • 概要
    • 法律規章上的架構
    • 市場展望
  • 美國的生技仿製藥
    • 概要
    • 法律規章上的架構
    • 市場展望
  • 印度的生技仿製藥
    • 概要
    • 法律規章上的架構
    • 市場展望
  • 韓國的生技仿製藥
    • 概要
    • 法律規章上的架構
    • 市場展望
  • 日本的生技仿製藥
    • 概要
    • 法律規章上的架構
    • 市場展望
  • 中國的生技仿製藥
    • 概要
    • 法律規章上的架構
    • 市場展望
  • 主要加入企業
  • 生技仿製藥的開發平台分析
    • 概要
    • 各開發階段
    • 各分子
    • 各治療區域
    • 各適應症
    • MoA/RoA
    • 開發後期的生技仿製藥
    • 第二階段開發平台的生技仿製藥
    • 第一階段開發平台的生技仿製藥
目錄
Product Code: GBI057CBR

Summary

Biosimilars are copied versions of biologics that offer a 20-50% reduction in cost compared with innovative biologic products. Biosimilars are getting the world wide attention as the cost of the innovative biologics are enormously high and even minimal reduction in price will reduce the healthcare spending substantially. All the countries are focusing on reducing the healthcare expenditure and biosimilars compliments to this goal. Biologic products are complex in structure and follow a complex manufacturing process thus, some variation exists between the reference product and its biosimilar. It is very important to assess the variations in biosimilars by comparing with reference product to ensure quality, non-clinical, and clinical properties, which has given rise to the regulatory requirements for biosimilars. Regulatory requirement for approving biosimilars varies across different regulatory bodies. However, all the countries have derived the basic theme from EMA and WHO guidelines for framing their regulatory structure. There is a need to harmonize the nomenclature of biosimilars, extrapolation of indications, and interchangeability of biosimilars with reference products across the regulatory bodies. Biosimilars market is developing and it could be well established with the pipeline that is poised to deliver a wave of biosimilars in the market in the near future

Scope

The scope of the report includes -

  • Introduction
  • Market dynamics: Trends, Drivers, and Barriers
  • WHO guidance for biosimilars
  • Regulatory overview, biosimilar guidelines, regulatory framework for biosimilars, and market outlook for: Europe, USA, India, South Korea, Japan and China.
  • Key players
  • Pipeline Analysis
  • Overview
  • By Stage of Development / Molecule / Therapy Area / Indication
  • Late-Stage / Phase II / Phase I Pipeline Biosimilars

Key Reasons to Purchase

The report will enhance your decision-making capability by allowing you to -

  • Understand the regulatory requirement and regulatory framework that facilitates effective product development strategy as biosimilars industry is currently highly focused, growing, and outpacing the growth rate of small molecule pharmaceutical market
  • Targeting geographies would be easy by comparing different regulatory frameworks; this would also provide a base for designing a strategy to enter the developed markets. Biosimilars are of interest in developed countries to reduce the healthcare expenditure
  • With the recent approvals of biosimilars by USFDA, the biosimilars market is going to grow and this report examines the post approval market landscape
  • Examine the biosimilars pipeline and specifies the products that are highly targeted, it also includes analysis of highly focused indications, mechanism of actions, and therapy areas in the pipeline
  • Analyze the details of the clinical pipeline that includes late stage products, Phase II, and Phase I products. Detailed understanding of the pipeline will help in targeting the products for development, rate the current products and predict the competition

Table of Contents

  • Executive Summary
  • Introduction
  • Biosimilars Industry Dynamics
    • Trends
    • Drivers
    • Restraints
  • Biosimilars Regulation: WHO's Guidance
  • Biosimilars in Europe
    • Overview
    • Regulatory Framework
    • Market Outlook
  • Biosimilars in the US
    • Overview
    • Regulatory Framework
    • Market Outlook
  • Biosimilars in India
    • Overview
    • Regulatory Framework
    • Market Outlook
  • Biosimilars in South Korea
    • Overview
    • Regulatory Framework
    • Market Outlook
  • Biosimilars in Japan
    • Overview
    • Regulatory Framework
    • Market Outlook
  • Biosimilars in China
    • Overview
    • Regulatory Framework
    • Market Outlook
  • Key Market Players
  • Biosimilars Pipeline Analysis
    • Overview
    • By Stage of Development
    • By Molecule
    • By Therapy Area
    • By Indication
    • By MoA/RoA
    • Late-Stage Pipeline Biosimilars
    • Phase II Pipeline Biosimilars
    • Phase I Pipeline Biosimilars
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