“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.
"Sometimes it feels as if we’re seeing the biosimilars version of ‘Groundhog Day,’" FDA Commissioner says of the tactics used to fend of competition to biologics.
The US FDA is taking a page out of the generic drug history book in its efforts to speed the development and marketing of new biosimilars and interchangeable products.
The agency’s new
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