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.
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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.
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
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
About
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For
more information visit: Radiant
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