Coherus cuts staff after FDA red light
- Coherus BioSciences disclosed in a filing with the Securities and Exchange Commission earlier this week that it will cut its staff by 51 employees, roughly 30% of its total workforce.
- The layoffs will decrease the biotech’s annual operating costs by about $10 million, but will cost the company approximately $3.7 million in restructuring costs.
- Coherus is making the cuts after a June 12 rejection from the Food and Drug Administration for its Biologics Licensing Application for CHS-1701, a biosimilar of Amgen’s Neulasta (pegfilgrastim).
"The Compensation Committee of the Board of Directors of Coherus BioSciences, Inc. approved, and management commenced and completed, a restructuring plan to reduce operating costs and better align its workforce with the needs of its business," Coherus said in the SEC filing.
The so-called realignment comes after the FDA dinged Coherus with a Complete Response Letter for its Neulasta biosimilar. According to the company, the FDA requested a reanalysis of some patient samples using a modified assay, as well as for further manufacturing-related process information.
This isn’t the first hiccup for the company, either. Coherus had announced previous studies of its Neulasta biosimilar did not show bioequivalence, prompting the company to conduct another study.
It is unclear how long, or how much money, the company will need to resolve the CRL. For the time being, Amgen gets a reprieve from a biosimilar. But don’t expect Amgen to be too worried. The big biotech — affectionately known around the industry as a lawfirm with scientists — has a swath of patent-protecting lawyers and Amgen has fought fiercely in the courtroom to keep biosimilar competition at bay.
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