FDA opened the regulatory phase of the biosimilar debate by hearing from industry and other stakeholders about what an approval system should look like. But this information-gathering session wasn’t all one-sided: FDA officials offered some hints of what they are thinking too. And while there are some significant areas of disagreement—and outlier positions—there was also quite a bit of common ground.
By Kate Rawson
As the final arbiter of an approval pathway for biosimilar products, the Food & Drug Administration is like a trapeze...
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Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
