Abstract
Overview
Introduction
The drive for increased cost savings by healthcare providers is increasing the
focus on boosting the biosimilar market. With a regulatory approval pathway in
place in Europe and substantial guidelines to support biosimilar development,
the European biosimilars market is significantly more advanced than the US,
where plans for a biosimilar regulatory approval pathway have stalled.
Scope
- Introduction to why biosimilars development is being pushed in Europe and
the US
- In-depth analysis of the US and European biosimilar regulatory environment
- Overview of the success of biosimilar approvals in the US and European
markets
- Identification of future trends shaping biosimilar regulatory environment
evolution
Report Highlights
Although the FDA was relatively pro-biosimilars from 1999-2004, the release of
regulatory guidelines for biosimilars has stalled significantly since the
resignation of Commissioner McClellan; furthermore, the FDA' s switch to a
stance of issuing broad biosimilars guidance first will require Congress
action, delaying biosimilar launches further.
The European regulatory environment is considerably more favorable for
biosimilar developers, with the release of a range of directives and
guidelines set to help guide biosimilar development; however, more clarity is
needed to clear up ambiguities in legislation and more strongly shape
biosimilar approvals.
In the future, the evolution of the biosimilars environment will largely
depend on whether the pro-biosimilars or the anti-biosimilars faction has
greatest influence over the regulatory authorities; in the US, the
pro-innovator biologics faction is currently more powerful, while in Europe,
the pro-biosimilars faction has had greater success.
Reasons to Purchase
- Understand the key regulatory frameworks for biosimilar approvals in the
US and Europe
- Build an understanding of how biosimilars have fared in the US and Europe
- Gain insight into how the biosimilars market is set to evolve in the future
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