Woodcock Bemoans Lack Of 'Biobetter' Provision In BPCIA
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.
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Calls to give up on biosimilars in the US are premature, former FDA commissioner Scott Gottlieb insists. Rather, he says, Congress should act to promote uptake and greater competition in the biologics arena.
Gottlieb Shifts From Regulatory To Reimbursement Focus In One Of First Post-Commissioner Appearances
CAR-T reimbursement is concern for former US FDA commissioner Scott Gottlieb in speech at the National Press Club.
“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.