viernes, 8 de marzo de 2019

FDA veers on biosimilar names, angering generic makers - STAT

FDA veers on biosimilar names, angering generic makers - STAT

The Readout

Damian Garde

Would a biosimilar with a four-letter suffix sell so sweet?


What’s in a name? When it’s a biosimilar and the FDA requires you to add four letters to the brand name of the drug you are almost copying, those are fighting words. Brand-name drug makers say biosimilars need distinctive names — with suffixes — to better track side effects, but generic drug makers assert those same suffixes will only confuse prescribers and pharmacists.

As Ed Silverman notes, yesterday’s draft guidance on the naming convention is an about-face for the FDA from two years ago, when it appeared to reject the requirement. But now, if a brand-name biologic is called GOODDRUG, the biosimilar version would be called GOODDRUG-ABCD.

The shift was met with derision by generic drug makers. No word from the people who dream up these drug names in the first place.

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