Regulatory Issues - Europe continues to make strides while the US lags behind

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.

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.

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