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First Biosimilar Reviews Raise Questions About the Differences

This article was originally published in The Gold Sheet

Executive Summary

DRUGS WON'T BE QUITE THE SAME in a biosimilar world, but does it really matter? Without better analytical technology, only clinical trials and post-marketing surveillance will tell. Global regulators are beginning to decide which differences they will allow, and on what basis. Recent approvals in India and China draw criticism at WCBP 2008 from Genentech official who explores uncertainties about growth hormones, other recombinants. The EU's new biosimilars framework and first approvals and denials are explained. Meanwhile, follow-on biologics regulation is planned by the World Health Organization, Japan and the U.S.

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