Research and Markets: Overview and Background of Biosimilars 2014: What They are and a Timeline of their Development

Research and Markets (http://www.researchandmarkets.com/research/l5983v/biosimilars) has announced the addition of the "Overview and Background of Biosimilars 2014: What They are and a Timeline of their Development" report to their offering.

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.

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.

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.

Scope:

• 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 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
19. Appendix

For more information visit http://www.researchandmarkets.com/research/l5983v/biosimilars