[September 11, 2014]

Research and Markets: Global Biosimilars Research Report 2014 - Biosimilars on the Cusp of a New Era

Research and Markets (http://www.researchandmarkets.com/research/mzkcs5/biosimilars) has announced the addition of the "Biosimilars - Biosimilars on the Cusp of a New Era" report to their offering.

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 (News - Alert).

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 experence 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.

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

Key Topics Covered:

1. Executive summary
2. Methodology
3. Biosimilars: an overview
4. Key concerns surrounding biosimilar use
5. Automatic substitution
6. A changing regulatory landscape
7. EMA guidelines
8. FDA guidelines
9. Considerations for the rest of the world
10. Recent developments in the biosimilars market
11. New biosimilar launches
12. Government/agency opinions
13. Implications for the marketplace
14. The future outlook
15. The biosimilar pipeline
16. Paradigm-changing potential
17. Key players
18. The way forward for industry

For more information visit http://www.researchandmarkets.com/research/mzkcs5/biosimilars

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