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US Capitol Capsule: Could another biosimilars fight be a brewin'?

This article was originally published in Scrip

Executive Summary

There was hardly time to yawn at the US FDA's unusually short 16 December meeting to discuss its proposed recommendations for a biosimilars user fee programme, with a handful of industry and other stakeholders getting straight to the point with their mostly anticipated comments and few questions raised by regulators at the less than two hour public event. But Christopher Ohly, a partner at the Washington law firm Schiff Hardin, predicted there's potentially a fight a brewin' based on comments made at the meeting unrelated to the user fees.


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