Biosimilar Hearing Will Consider Whether 'Umbrella' Exclusivity Policy Warranted
US FDA asks for comments on whether the policy employed for small molecule generics also should apply to biosimilars.
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“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.
In unveiling the agency’s Biosimilar Action Plan, FDA's Gottlieb continued his pattern of provocative remarks by criticizing brand company practices and payment models that impede biosimilar competition and could ultimately undermine innovation. He also called for more action by the Federal Trade Commission and downplayed the impact interchangeability could have on biosimilar uptake.
'This is important for our own pharmacovigilance,' US FDA commissioner says. 'We still have an open question on whether or not we’re going to apply a suffix or change also the branded company’s name as well.'