Just two weeks after the FDA spurned Coherus’ application to sell a knockoff of Amgen’s Neulasta, the biosimilar maker has come back with a plan to ax 51 staffers — about 30% of its employees — as it hunkers down to weather the derailment.
The news earlier this month marked a reprieve for Amgen, which counts this drug as one of its mainstays. Amgen has been both lucky and good at holding off biosimilar competition to its aging flagship drugs, with Pfizer getting its second delay after the FDA found problems with its manufacturing site in Kansas. And that pitch had been blessed by inside and outside experts at the agency.
It’s uncertain just how much time Coherus will need before it refiles. The FDA asked for a new analysis of samples using a revised immunogenicity assay along with more info on the manufacturing process. The biotech says it was not asked for more data from a new trial.
Neulasta earned $4 billion last year, and Coherus says it isn’t quitting now.
The FDA has been picking up the pace on biosimilar approvals in the past year, with Novartis and others starting to gain steam in fielding their portfolios. But even when the clinical road to an approval looks more clear than ever, the FDA still looks ready to hit the brakes when it needs answers to its questions.
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