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.
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.
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