Much “Ado” About Biosimilars
This article was originally published in RPM Report
The approval of Kadcyla gives Roche/Genentech yet another new breakthrough cancer therapy in the US. It also offers some clues about the future of biosimilars at FDA.
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Several recent events have ratcheted up the pressure on the Obama Administration to offer some finality on the ongoing naming debate for biosimilars.
An unusual footnote in FDA’s approval letter for Takeda’s long-delayed diabetes medicine means that the company won’t have to worry about losing five-year exclusivity on the molecule.
Genentech appears to be having significant manufacturing problems for some of its new cancer therapies. FDA hasn’t taken enforcement action yet, but the agency has delayed two approvals and tied them to post-market requirements to address QC issues.