ASBM Executive Director Michael Reilly was quoted in the FDA News article by Robert King.
From FDA Draft Guidance Sets Rules for Biosimilar Meetings:
The FDA recently tiptoed into largely uncharted waters, issuing draft guidance laying out the ground rules for formal meetings between review staff and makers of biosimilars.
The document, which provides particulars on scheduling, preparing and conducting a formal meeting, appears to be an effort to “get the ball rolling” on a new process that many drugmakers are still struggling to comprehend, said Michael Reilly, executive director of the Alliance for Safe Biologic Medicines.
“I think that the applications aren’t rolling in yet because people are still trying to figure out what an application process is going to look like,” Reilly said. “Are you doing a BLA or a biosimilar application? That is a decision that manufacturers and investors have to make.”
Read the full article here.