IGBA Still Sees A Path To Change FDA’s Mind On Biologic Suffixes

03 Apr 2019

In the second of three exclusive interviews with IGBA secretary general Suzette Kox and chair Jim Keon, Kox provides the latest update on worldwide issues around biosimilars, particularly naming conventions.

Digital globe — The IGBA’s Secretary General And Chair Give Us The Latest On Global Issues Affecting The Generics And Biosimilars Industries • Source: Shutterstock

In recent months, a global debate around naming conventions for biosimilars has once again flared up – as a result of a recent decision by Health Canada and newly-published draft guidance from the US Food and Drug Administration (FDA) – and the International Generic and Biosimilar medicines Association (IGBA) has not shied away from weighing in on the controversy.

Following Health Canada’s recent decision to not add suffixes to non-proprietary names for biologics, including biosimilars – leaving the US...