FDA Recommends Extension of Evaluation Times for Biosimilars

The FDA is proposing to extend review times to enable more communication between the agency and sponsors to increase the number of first cycle approvals for biosimilars.

According to the minutes of a March 31 meeting discussing the planned update to BsUFA, the FDA recommended establishing a review model similar to the one used in the last update of PDUFA, including a review clock that begins on the 60-day filing date, a mid-cycle communication and a late-cycle meeting.

The current iteration of BsUFA is set to expire in September 2017 and must receive congressional approval for renewal. BsUFA currently has a 10-month review goal and lacks a formalized structure for communication between the FDA and industry.