FDA Will Unveil Four Draft Guidances on Biosimilars This Year

Thursday, May 28, 2015

Source: FDA News

The FDA is on track to release draft guidance on naming biosimilars this year, an FDA official said last week.

The guidance has been long in coming, in part because the agency wants to avoid adopting a naming system that will confuse people or put biosimilars at a disadvantage, and it wants a system that allows for safe use and pharmacovigilance, Sally Howard, deputy commissioner for policy, planning and legislation, said during a meeting sponsored by the Alliance for Health Reform in Washington, D.C.

Three other biosimilars draft guidances — covering labeling, statistical approaches to evaluation of analytical similarity data, and considerations in demonstrating interchangeability to a reference product — also are expected this year, Howard said.

View All News »