Look out, Neulasta: A 5th biosimilar is coming

27 May 2022
endpts.com
BiosimilarGeneric Drug
As Neulasta sales slip, Amgen has yet another biosimilar to look out for: Amneal Pharmaceuticals and Kashiv Biosciences’ Flynetra. Flynetra became the fifth approved biosimilar to Neulasta on Friday, snagging a win in neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell that fights infection, are too low. As of last summer, the list price of Neulasta was more than $6,400 per dose. It’s designed to be taken in a single dose per chemotherapy cycle. Amneal declined to reveal how much it intends to charge for Flynetra in an email to Endpoints News. “Biosimilars represent the next wave of affordable medicines and are closely aligned with our mission to provide high quality, affordable medicines to as many patients as possible,” co-CEOs Chirag and Chintu Patel said in a news release. This isn’t Amneal’s first successful crack at an Amgen oncology drug. Earlier this year, the New Jersey-based company swung an approval for Releuko, a biosimilar to Amgen’s Neupogen, which is designed to stimulate the growth of white blood cells after cancer treatment. It also won an OK for Alymsys, a copycat of Genentech’s Avastin. All three products are expected to launch in the second half of this year, Amneal said. Neulasta, one of Amgen’s oldest drug franchises, has struggled amid rising pressure from cheaper generics. While Neulasta brought in more than $4 billion back in 2016, sales topped out at just $1.7 billion last year, down 24% from the year before that. The first Neulasta biosimilar, Vitris’ Fulphila, won approval in 2018 — and the following year, Neulasta sales fell 28% to $3.22 billion. The lowest retail price for Fulphila, according to GoodRx , is around $2,400, which is a near 60% discount from the average retail price of Neulasta. Pfizer’s Nyvepria, Coherus’ Udenyca, and Sandoz’s Ziextenzo are also approved as biosimilars to Neulasta. While the advancement of biosimilars has been sluggish — due in part to fierce opposition from pharma companies making top-dollar on their original biologics — Cardinal Health researchers said earlier this year that momentum is gaining. “2022 is set to be a turning point in the U.S., as biosimilars expand into new therapeutic areas and sites of care, and reimbursement models continue to evolve,” Cardinal Health’s specialty solutions president Heidi Hunter told Endpoints. The first biosimilar ever approved, Zarxio, also targeted an Amgen drug, Neupogen. Since then, the adoption of biosimilars started slow but has accelerated more recently. Last year marked several milestones in the biosimilars space, including the approval of Viatris’ Semglee as the first interchangeable biosimilar, the first OK for a biosimilar in ophthalmology, and the first interchangeability designation for a biosimilar to AbbVie’s blockbuster Humira. Amgen’s Amjevita will be the first Humira biosimilar to come to market, starting next January. Meanwhile, the FDA’s Office of Prescription Drug Promotion took issue last summer with so-called misleading banner ads for Neulasta. OPDP noted in an untitled letter that certain claims and presentations in the ads “create a misleading impression regarding the benefit of the product.” For example, Amgen said in the ads that there is a statistically significant higher risk of febrile neutropenia when Neulasta is administered via the prefilled syringe compared to its Onpro on-body injector. “However, the multiple limitations of the cited study preclude the drawing of such conclusions regarding the comparative risk of febrile neutropenia (FN) in patients taking pegfilgrastim depending on delivery method,” the FDA said. The misleading claims could also have an effect on biosimilars, the agency warned:
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