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Biosimilar Interchangeability Guidelines on Track for 2016 Release, Woodcock Says

October 28, 2016

The FDA will release biosimilar interchangeability guidelines on schedule by the end of the year, CDER Director Janet Woodcock confirmed.

The BsUFA II performance goals committed the FDA to issuing guidance by December 2017 on biosimilars that can be substituted for a reference product without a prescriber’s intervention, but the document will be available one year before then, Woodcock told the GPhA Fall Technical Conference.

Drugmakers have been seeking clarification on how to prove biosimilar interchangeability since 2011. Moreover, companies have requested specific standards for their approval.

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