Title: Biosimilars Bring Much-Needed Competition to Drug Markets
1Biosimilars - Biosimilars on the cusp of a new
era
(Type, Mode of action, Crop Type and Geography) -
Size, Share, Global Trends, Company Profiles,
Demand, Insights, Analysis, Research, Report,
Opportunities, Segmentation and Forecast, 2013 -
2020
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Published on Oct 2014
2 Report Overview
- 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. - Read More At http//www.researchbeam.com/biosimi
lars-biosimilars-on-the-cusp-of-a-new-era-market
3 Report Overview
- 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 PR 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
4 Table of Content
Executive summary Methodology Biosimilars an
overview Key concerns surrounding biosimilar
use Automatic substitution A changing regulatory
landscape EMA guidelines FDA guidelines Considerat
ions 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-ch
anging potential Key players The way forward for
industry Appendix Enquire At
http//www.researchbeam.com/biosimilars-biosimilar
s-on-the-cusp-of-a-new-era-market/enquire-about-re
port
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