FDA Chief Blames Drug Supply Chain for Hampering Biosimilars

Consolidation within the drug supply chain is keeping cheaper versions of complex drugs from reaching patients despite high drug approval rates, Scott Gottlieb, head of the FDA, said Sept. 4.

The Food and Drug Administration has approved 12 biosimilars—six were approved last year alone. But fewer than half of these drugs have actually been marketed to patients, putting a damper on the agency’s historically high drug approval levels.

Consequently, patients sometimes pay exorbitant amounts for biologic drugs despite cheaper versions being available because consolidation “can work in favor of the incumbent reference biologic and discourage adoption of biosimilar competitors,” Gottlieb ...