Amgen accuses biosimilar producer of ‘massive conspiracy’
Amgen has filed a lawsuit in a Californian state court against Coherus Biosciences, suggesting that Coherus had stolen trade secrets. The case is in regards to the development of Coherus’ biosimilar to Amgen’s Neulasta.
The actual wording accuses Coherus of a ‘massive conspiracy’ through the hiring of former Amgen employees, who are then alleged to have stolen USB drives with sensitive information. On top of this there is the suggestion that Amgen standard operating procedures, lab notebook pages, validated analytical methods, method development reports, specifications, documents reflecting process optimization work, cost calculators, and pricing and contracting strategies may have also been taken to Coherus by ‘disloyal former Amgen employees’, according to Amgen.
Coherus have reacted by vehemently denying the suggestion. “Coherus believes that this action is without merit and will defend against it vigorously,” said Denny Lanfear, President and Chief Executive Officer of Coherus. “We categorically reject the theme of Amgen’s complaint that Coherus has engaged, or is engaging, in a scheme to misappropriate trade secrets or commit other wrongdoing. Coherus believes this lawsuit is best understood as an effort by Amgen to use baseless litigation in an effort to delay Coherus as a competitor in the pegfilgrastim market.”
Lanfear’s line of argument holds some sense, It would not be the first time that a pharmaceutical company had used legal proceedings in an attempt to delay a biosimilar to coming to market; this is particularly so given the sales figures for Neulasta, which managed $4.6 billion in sales for Amgen in the previous year.
Neulasta is a treatment which helps protect against the risk of infection and provides support to patients who are receiving chemotherapy. The drug is administered through an injection 24 hours after a patient has received chemotherapy.
The FDA decision date on Coherus’ biosimilar is due on 9 June. The lawsuit may well cause issues in the process of the application.