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