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Biosimilars - Biosimilars on the cusp of a new era

  • July 2014
  • -
  • GBI Research
  • -
  • 58 pages

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.


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

ScopeKey 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 Contents

Biosimilars - Biosimilars on the cusp of a new era
Executive summary
Biosimilars: 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
The future outlook
The biosimilar pipeline
Paradigm-changing potential
Key players
The way forward for industry

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