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Biosimilars Trigger Analytical Frenzy as Innovators Look to Update Methods

This article was originally published in The Gold Sheet

Executive Summary

As biosimilar developers ‘fingerprint’ molecules with state-of-the-art assays in hopes of winning reduced clinical trials or more, innovators are updating their analytical methods, hoping to alert FDA before their competitors about any issues the old methods may have missed. As the ‘totality of the evidence’ on their molecules increases exponentially, concerns are raised about the proliferation of non-critical specifications.

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