Large Molecule / Generic

Coherus Cuts Staff by 30% After FDA Rejects Biosim

Jun 29, 2017

San Fran Business Times

Coherus BioSciences has eliminated 51 jobs after failing to win FDA approval for a biosimilar version of Amgen's bone marrow stimulant, Neulasta.

The Bay Area-based drugmaker made the layoff decision after receiving the FDA's complete response requesting a reanalysis of some clincial trial data submitted in the marketing application as well as more information on manufacturing processes. Coherus CEO Denny Lanfear said in a Securities and Exchange Commission filing that the layoffs will reduce annual costs by $10 million.

Amgen's top-selling Neulasta is used to treat a shortage of infection-fighting white blood cells in cancer chemotherapy patients, and costs around $5,000-$7,000 per injection.

In March, Amgen filed a trade secret action against Coherus, claiming that Coherus has been poaching its employees and using stolen trade secrets to expedite its biosimilar production process.

Read the San Fran Business Times article