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.
Coherus is also developing a biosimilar of Amgen’s rheumatoid arthritis treatment etanercept (Enbrel) and Abbvie’s adalimumab (Humira).
Eye on Pharma: Bevacizumab Update; Samsung Bioepis, J&J Settlement; Another EU Trastuzumab
December 6th 2023Outlook Therapeutics provides an update on the development of its bevacizumab candidate for age-related macular degeneration; Samsung Bioepis settles with Johnson & Johnson (J&J) over its ustekinumab biosimilar candidate; and the European Union gains another trastuzumab biosimilar.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
Biosimilars Regulatory Roundup for September 2023—Podcast Edition
October 1st 2023On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).