GPhA To FDA: Naming Changes Must Apply Retroactively To All Biologics

The Generic Pharmaceutical Association -- about a week before the World Health Organization formally unveiled a biosimilar naming proposal -- met with FDA to lay out its position, saying any change to the current system must apply to all biologics and retroactively, according to slides from the meeting. GPhA officials, lobbyists and several member company representatives met July 24 with Sally Howard, deputy commissioner for policy, planning and legislation, according to FDA records. At the meeting the group also reinforced...