Biosimilars Market Analysis - Biosimilars on the Cusp of a New Era - Global Industry Size, Share, Trend, Forecast, Analysis and Growth

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.

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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.

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...