BIOSIMILARS - Regulatory Framework and Pipeline Analysis

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BIOSIMILARS - Regulatory Framework and Pipeline
Analysis
Size, Share, Global Trends, Company Profiles,
Demand, Insights, Analysis, Research, Report,
Opportunities, Segmentation and Forecast
Published Date Jun 2015
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Report Description
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 Get Complete Report
At http//www.bigmarketresearch.com/biosimilars-r
egulatory-framework-and-pipeline-analysis-market
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Report Description
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 Enquire
About this Report at http//www.bigmarketresear
ch.com/report-enquiry/311220
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Report Description
Reasons to buy 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
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Table of Contents
Executive Summary 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 Regula
tory Framework
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Table of Contents
Market Outlook Biosimilars in Japan Overview Regul
atory 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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