Biosimilars Market - Biosimilars on the cusp of a new era Market Research Report

<strong>Biosimilars</strong> -
<strong>Biosimilars</strong> on the
cusp of a new era
<strong>Market</strong> Research
Report
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Report Description
About <strong>Biosimilars</strong> <strong>Market</strong>
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.
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Report Description
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 P&R 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
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Report Description
Key Reasons to Purchase
- The report will Provide an in-depth insight into recent biosimilar regulatory
developments including a comparison of the processes used in different markets and
the guidance being implemented.
- Assess the biosimilars pipeline including where development is currently focused and
the potential impact new biosimilars will have on the marketplace.
- Highlight industry opinions towards biosimilars and their expected impact in different
therapy areas and how industry can meet the challenges being presented by
biosimilar development and launches.
- Provide an understanding about the key concerns around biosimilar development and
use, including manufacturing concerns and issues around automatic substitution.
- Provide an overview of the key companies involved in the biosimilar market including
an analysis of where the majority of biosimilar companies are located, the markets in
which they operate and the future outlook.

Table Of Content
Executive summary
Methodology
<strong>Biosimilars</strong>: an overview
Key concerns surrounding biosimilar use
Automatic substitution
A changing regulatory landscape
EMA guidelines
FDA guidelines
Considerations for the rest of the world
Recent developments in the biosimilars market
New biosimilar launches
Government/agency opinions
Implications for the marketplace
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