Sandoz US President Peter Goldschmidt Talks Generic Policy Improvements
The US is behind other markets when it comes to complex generics and biosimilars, Goldschmidt said, though he is hopeful new FDA Commissioner Gottlieb and the new administration will explore ways to make approval of hard-to-replicate drugs faster.
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US agency could reconsider requirement that instructions for use be same for branded and generic products, FDA Commissioner-nominee Scott Gottlieb suggests, while also leaving door open to statutory changes in Hatch-Waxman Act.
Agency declined to say whether ANDA sponsors would need to meet requirements requested by Sandoz; Mylan's generic user fee date is March 28.
As more generic applications arrive, Office of Generic Drugs staff may have a tougher time reaching review goals.