Avoiding ‘Groundhog Day’: US FDA’s Biosimilar Action Plan Applies Lessons From Generic Competition
“We’re not going to wait a decade or more for robust biosimilar competition to emerge,” Commissioner Scott Gottlieb says, noting reference biologic sponsors are repeating some of the delay tactics honed in the small molecule space to keep competition at bay.
You may also be interested in...
Interchangeability Won’t Solve US Biosimilar Market’s Woes, FDA’s Gottlieb Says
FDA's Biosimilar Action Plan aims to boost approvals, but Commissioner Gottlieb says he's had a change of heart about how much impact an interchangeability designation can have on market uptake.
Biosimilars For US Market May Be Able To Rely On EU-Licensed Reference Products
Commissioner Scott Gottlieb says move could allow biosimilar sponsors to avoid anti-competitive efforts by brand sponsors in US.
One Lesson Of The OND Reorg: It Is Hard To Classify Diseases
One goal of proposed overhaul of US FDA’s Office of New Drugs is creating more logical alignment of related diseases within divisions and offices. That is easier said than done.