SPOTLIGHT: FDA sees long road for biosimilar approvals


A senior FDA administrator, Janet Woodcock, told lawmakers that it could be a decade or more before the agency could approve generic biotech drugs with the same kind of speed used for traditional meds today. That's likely to be music to the ears of big biotech outfits like Amgen and Genentech, which would be among the first affected by a new pathway to biosimilars. Report

Suggested Articles

Silverback Therapeutics reeled in $85 million to advance its lead antibody-drug conjugate through the clinic and develop its earlier-stage pipeline.

The reported requirements suggest a company is unlikely to have the data needed to support an EUA before the election in six weeks.  

Blocking tau appears to be just as fruitless as clearing amyloid buildup when it comes to helping Alzheimer’s disease patients.