Keeping Track: US FDA Approves Zokinvy, Defers Liso-Cel, Declines ALKS 3831 And Zimhi; Two Biosimilars Filed

Non-approvals outweighed approvals at the US Food and Drug Administration this week. Bristol Myers Squibb Company’s highly anticipated CAR-T therapy lisocabtagene maraleucel (liso-cel) remains unapproved after its user fee goal, waiting for FDA manufacturing inspections to resume, but that’s relatively good news compared to Alkermes plc’s ALKS 3831 and Adamis Pharmaceuticals Corp.’s Zimhi, where the agency found sufficient quality issues within pandemic constraints to issue complete response letters.

The FDA nonetheless closed out the week with a novel, breakthrough therapy-designated approval for Eiger BioPharmaceuticals, Inc