Amgen has filed a legal action in California state court against Bay Area biosimilar maker Coherus Biosciences, Inc, alleging that since 2014 Coherus has engaged in a “massive conspiracy” to steal trade secrets for Amgen’s reference biologic pegfilgrastim (Neulasta). The drug, a pegylated form of recombinant human granulocyte colony-stimulating factor, is indicated to reduce the incidence of infection in patients with non-myeloid malignancies who are receiving myelosuppressive anticancer agents. Coherus’ biosimilar to pegfilgrastim (CHS-1701) is currently scheduled for a June 9, 2017, regulatory hearing at the FDA concerning its approval.
The lawsuit asserts that Coherus induced multiple Amgen employees to breach confidentiality agreements regarding Amgen’s pipeline in order to gain proprietary knowledge, allegedly receiving such information on “stolen” USB drives. This included sensitive 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. Amgen is seeking restitution and damages. The lawsuit also names former Amgen employees, including Howard S. Weiser, currently executive director at Coherus, as having violated trade secrets.
Coherus categorically rejected the allegations as baseless and accused Amgen of using the lawsuit to prevent potential competition from the biosimilar product, should it be approved. Danny Lanfear, president and CEO of Coherus, said the action is without merit and the company would defend against it vigorously. “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,” he said in a statement.
Lanfear went on to deny that his company needed Amgen’s proprietary information to compete or be successful, adding that he is proud of Coherus’ novel clinical development strategy and novel clinical study designs—none of which were ever performed at Amgen and are not Amgen’s intellectual property. Barclays analysts said the alleged violations occurred well after Coherus developed CHS-1701.