1. Pink Sheet

Biosimilars: US FDA Expecting More Applications, Fewer Applicants

 
• By Nielsen Hobbs

Preparing biosimilar applications still takes as much time as it would for an original BLA, FDA says.

Projection screen on the stage.
US FDA's biosimilar projections usually aren't this dramatic, but they do tell a story.

The US FDA is revising upwards the number of biosimilar applications it expects in coming years – but revising downward the number of applicants that it expects to submit.

FDA is projecting an average of nine applications in the coming years, according to a Federal Register notice scheduled...

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