Biosimilars - Biosimilars on the Cusp of a New Era

Hexa Reports

Market Research Reports and Insightful Company Profiles

Biosimilars Regulatory Framework Market Share,

Size, Trends, Growth, Analysis and Outlook Research

Report by Hexa Reports

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.

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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

Hexa Reports

Market Research Reports and Insightful Company Profiles

- An overview of the issues around automatic substitution with biosimilars

- The regulatory landscape for biosimilars, including a comparison of FDA and EMA guidelines

- Recent...