US FDA's Biosimilars Program: Five Years In, Complete Response Letters Still Outnumber Approvals

29 May 2018

Agency is meeting its review timelines for biosimilar applications but handing our more complete response letters than first-cycle approvals; sponsors have publicly disclosed 24 original biosimilar application submissions to the agency since the review program began in fiscal year 2013, with 10 product approvals to date and at least 13 CRLs, according to the Pink Sheet's biosimilars report card.

The US FDA’s biosimilar application reviews continue to remain stellar as far as user fee performance goal timelines go, but the end result more often than not is a complete response letter.

As it has since the Biosimilar User Fee Act (BsUFA) program began in fiscal year 2013, the agency met its...