NEW YORK, July 28, 2015 /PRNewswire/ -- 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
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
Read the full report:
http://www.reportlinker.com/p03087009-summary/view-report.html
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