On November 17, 2015, the FDA finalized a guidance document, that was first issued as a draft in March 2013, regarding formal meetings between the FDA and biosimilars applicants. Because meetings with biosimilars applicants are critical points in the regulatory and development process, the FDA reiterated the importance of having efficient, consistent procedures for the timely and effective conduct of such meetings. According to the FDA, this guidance document is intended to provide consistent procedures that will promote wellmanaged meetings, and ensure that such meetings are scheduled within a reasonable time, conducted efficiently, and documented appropriately.

The final guidance does not differ significantly from the draft of 2013, and maps out the five types of meetings that a biosimilars applicant can request with the FDA.