In the coming weeks, the Food and Drug Administration is scheduled to release its Biosimilar Innovation Plan which is intended to “promote the development and adoption of safe, high quality biosimiliar drugs.” FDA Commissioner Scott Gottlieb has stated a robust biosimilar market will demand “potentially disruptive” solutions.
Avalere Health’s Gillian Woollett wrote an article on biosimilars and three ways the FDA can facilitate claims of interchangeability – noting that interchangeability designation is perceived as the “holy grail” by some, and regarded as irrelevant by others. Woollett writes that as a legal matter, the interchangeable “designation is only relevant for substitution by pharmacists (subject to state law); thus, it is not applicable to physician-administered drugs, which represent the vast majority of biologics.
Read Woollett’s article or news coverage by the Center for Biosimilars who noted, “Woollett’s suggestions are in line with some broader trends in the conversation about biosimilars, interchangeability, and competition; FDA Commissioner, Scott Gottlieb, MD, recently stated in an interview that he sees drug companies ‘gaming the system to try to block competition’ in many ways within the current marketplace, and he wants to ‘end the shenanigans.’ One ways to do so, said Gottlieb, is do away with expensive bridging studies.”
Avalere Health Insights Article (February 19, 2018) Three Ways the FDA Can Facilitate Claims of Interchangeability by Gillian Woollett
The Center for Biosimilar (February 22, 2018) How to Encourage Interchangeable Biosimilars? Available, Global Reference Products and Meaningful Studies by Samantha DiGrande