Novel Biologics In US Might Not Start Getting Suffixes Until August

FDA has cleared four novel biologics without a suffix despite finalizing nonproprietary naming guidance; the agency requests sponsors submit proposed suffixes at the time a BLA is submitted.

the word suffix on cubes

In January, the US FDA finalized a guidance that changes the way biologic products should be named. So far, the agency hasn't been following it.

Over the course of a week last month, FDA approved three novel biologics – Genentech Inc.'s multiple sclerosis treatment...

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