Amgen's Neulasta gains another biosimilar competitor as sales slip
Neulasta, one of Amgen’s oldest drug franchises, has another biosimilar to contend with.
German pharma Fresenius Kabi announced on Tuesday that the FDA has approved its pegfilgrastim biosimilar, to be marketed as Stimufend. The drug will add to a growing arsenal of biosimilars used to treat neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell, are too low.
Stimufend is specifically indicated for use in “patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia,” Fresenius said in a statement. It’s also the company’s first FDA-approved biosimilar.
The move comes just a few months after Kashiv Biosciences won an approval for its Neulasta biosimilar Fylnetra. The Amgen blockbuster has wrestled with biosimilar competition since the first one, Viatris’ Fulphila, won approval in 2018.
The following year, Neulasta sales fell 28% to $3.22 billion. Pfizer’s Nyvepria, Coherus’ Udenyca, and Sandoz’s Ziextenzo have also entered the market since then, sending sales on a downward spiral. The drug earned Amgen just $1.7 billion last year, down 24% from the year before that.
This past quarter, Amgen’s Neulasta sales topped out at $310 million, down 36% from Q2 2021.
As of last summer, the list price of Neulasta was more than $6,400 per dose. It remains unclear what Fresenius will charge for its version. The company was not immediately available for an interview.
Fresenius will launch Stimufend in a prefilled syringe early next year, according to a news release, and will subsequently seek approval for an on-body injector version.
Amgen got in trouble with the FDA’s Office of Prescription Drug Promotion last summer over so-called misleading banner ads, in which the company claimed there’s a statistically significant higher risk of febrile neutropenia when Neulasta is administered via the prefilled syringe compared to its Onpro on-body injector.
“The above misleading claims and presentations are particularly concerning from a public health perspective because they could undermine confidence not just in Neulasta delivered via PFS but also in FDA-licensed biosimilar pegfilgrastim products, which are only delivered via PFS,” the FDA said.
Nyvepria, Udenyca and Ziextenzo are also administered via prefilled syringe, according to prescribing information.