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.
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A Washington Post article on price hikes for Abbvie’s Humira highlights patent ‘thickets’ and anti-biosimilar strategies. But the lack of understanding of the basic concepts of the biosimilar system are a much bigger warning sign about the viability of the pathway.
CDER director lobbied for inclusion of a 505(b)(2)-like category for biologics, but it was ultimately not included in the 2010 legislation creating the biosimilar pathway; Woodcock urges patience on the development of the biosimilar marketplace and notes the agency will be keeping an eye on the development of biobetters, which are relatively new innovations.