Trying to carve back its market share for Neupogen, its filgrastim originator product, Amgen is hoping product exclusivity can be backdated.
If a pharmaceutical company receives a patent long after competitor versions of its drug have come to market, can that company still bring a suit for lost profits and patent infringement? Amgen is trying to do just that.
Amgen has filed suit against Hospira and Pfizer over a patent involved in the manufacture of a filgrastim biosimilar to Neupogen, Amgen’s reference product.
The biosimilar in question, Nivestym, received FDA approval in July of 2018 and went on market in October of that year. The patent under dispute (No. 10,577,392) was issued on March 3, 2020.
Amgen said the patent concerns methods of purifying proteins used in the manufacture of the biological product, contending, “Before the expiration of the patent,” Hospira, acting “in concert” with Pfizer, sought regulatory approval for the biosimilar under the abbreviated Biologics License Application (BLA) pathway in the Biologics Price Competition and Innovation Act.
Nivestym was approved by the FDA for all indications of the reference product, among them lowering the incidence of infection, caused by febrile neutropenia, in patients with nonmyeloid malignancies receiving chemotherapy. Neupogen stimulates the production of a known as neutrophils, a type of white blood cell that fight the infection.
Amgen contends that by September 24, 2018, Hospira and Pfizer were importing the biosimilar into the United States and making it available for sale. The company wants to recoup profits that it claims would otherwise have been made on the sale of Neupogen had there been no infringement as alleged.
Price erosion was partly responsible for those alleged lost profits, Amgen contens, citing a 2018 statement Pfizer made to The Center for Biosimilars® that Nivestym would be offered at a wholesale price 30.3% lower than that of reference filgrastim and 20.3% lower than that of Zarxio, a filgrastim biosimilar produced by Sandoz.
Amgen said in its court filing that it has had to battle obtain a full copy of the BLA from Hospira. Initially, Hospira provided 10,000 pages worth of material, but upon checking the cross-referencing, Amgen noticed that much of the document was missing. Hospira eventually produced an additional 70,000 pages, claiming that the extra pages were “inadvertently” not included with the original paperwork, Amgen contends.
Amgen, which is seeking a jury trial, initially contended that as many as 6 patents could be subject to a claim of infringement by Hospira. In subsequent negotiations, that number was whittled down to just 1 patent, covering the purification process for reference filgrastim. This patent remains under litigation in Delaware.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.