Amgen, J&J settle ustekinumab patent lawsuit in potential biosimilar market shake-up
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Key Takeaways
- Amgen will be allowed to sell its Stelara biosimilar “no later than Jan. 1, 2025.”
- Whether the development with ustekinumab will lead to cost savings and increased access remains to be seen.
Johnson & Johnson has settled its lawsuit with Amgen regarding the latter company’s Stelara biosimilar, clearing the way for a January 2025 release date in the United States, according to results of a federal court filing.
Meanwhile, the rheumatology world awaits the debut of other ustekinumab biosimilars in the market — and what they may portend for patient care moving forward — as the U.S. patents on the originator expire in September.
“Subject to FDA approval and the terms of a confidential settlement agreement with Johnson & Johnson, ABP 654 may offer appropriate patients and their physicians another treatment option for certain inflammatory diseases affecting millions of adults worldwide,” Janet Franklin, vice president of Global Development Biosimilars at Amgen, told Healio. “We are well-positioned to support the launch of ABP 654 by using our best-in-class manufacturing and commercialization engine, alongside decades of experience in inflammation, to provide eligible patients access to ustekinumab.”
Johnson & Johnson filed the initial patent infringement suit on behalf of its subsidiary Janssen in November 2022, alleging Amgen’s biosimilar ABP 654 infringed on two of its patents. A recent statement from Amgen indicated that the company will be allowed to sell its biosimilar product “no later than Jan. 1, 2025,” pending approval from the FDA.
Meanwhile, another settlement agreement announced in June, this time between Johnson & Johnson, Alvotech and Teva Pharmaceuticals, will allow another ustekinumab (Stelara, Janssen) biosimilar, AVT04 (Alvotech), to enter the U.S. market no later than Feb. 21, 2025, pending FDA approval.
Stelara has enjoyed market exclusivity as the only ustekinumab product since its FDA approval in 2017. The top-selling drug boasted $6.39 billion in U.S. sales in 2022, according to reports.
Representatives from Johnson & Johnson did not respond to multiple requests for comment.
Although some may be tempted to view the results of this lawsuit as the opening of yet another floodgate of biosimilars — following the influx of adalimumab (Humira, AbbVie) biosimilars into the U.S. market this year — Amelia Bond, PhD, assistant professor in the population health sciences department at Weill Cornell Medical College, offered a more measured take.
“In the short term, not a lot is going to change,” Bond said, noting the January 2025 launch date. “When the medication does come to market, it takes time for clinics to stock new medications and perhaps most importantly, for payors to add new medications to their formulary.”
However, when the new ustekinumab biosimilar does become available, U.S. clinicians should be able to make immediate use of it, according to Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern Medicine, and Clifford Joseph Barborka professor of medicine at the Northwestern University Feinberg School of Medicine.
“The immune-mediated inflammatory disease community of dermatologists, rheumatologists and gastroenterologists are becoming increasingly familiar with biosimilars since the approval of several to Remicade (infliximab, Janssen) and most recently Humira,” he said. “There has been gradual acceptance for biosimilars in each specialty.”
The availability and acceptance of new medications can translate into cost savings and improved access for patients. However, whether the recent development with ustekinumab represents a large or small step toward those goals remains to be seen.
Requiring ‘different authorizations’
According to Hanauer, the immediate impact of one or more new ustekinumab biosimilars on the prescribing habits of the average rheumatologist may be minimal, for reasons that have little to do with physician preference.
“It is unlikely that practitioners will ‘prescribe’ specific biosimilars, as each third party is likely to have their own preferences based on negotiations with drug companies,” he said. “Likewise, with nearly 10 biosimilars anticipated for Humira, it is unlikely that a hospital/pharmacy formulary will include more than a few options.”
As such, many rheumatologists, including Hanauer, may feel somewhat powerless regarding the way this system is set up.
“Unfortunately, the transparency for selecting specific formulations based on the numerous third-party payers will allow practitioners to select a specific biosimilar in advance of submitting authorization request,” he said.
It is also worth noting that the patient and practice services provided for the originator drug have established a benchmark for what biosimilar manufacturers need to match, according to Hanauer.
“Stelara’s biosimilars will be the first such products that will require both hospital and pharmacy coverage, which require different authorizations from third party insurers as well as different co-payments from patients,” he said.
As if the pricing structure of medications in the United States is not complicated enough, this wrinkle may make it even more difficult to predict what the new ustekinumab biosimilars will cost.
‘The market has not been moved’
“Generally, biosimilars come to market with lower prices,” Bond said. “However, there has been variation in price reductions.”
The obvious place to look for clues about pricing should be previously released biosimilars. However, Hanauer believes that the cost scale of one originator and its biosimilars may not apply to the next originator/biosimilar pairing.
“Thus far, the market has not been moved with infliximab biosimilars to produce the anticipated cost-savings now seen in Europe, in a significant part due to price negotiations for the originators,” he said. “However, some recent approvals for adalimumab may reach as much as 85% cost reductions.”
However, with insurance carriers and pharmacy benefit managers being involved, the impact on patient wallets remains unclear.
“It remains to be established who will benefit from these ‘savings,’” Hanauer said.
Regarding the current landscape, the release of a single ustekinumab biosimilar may not move the cost needle too significantly, according to Bond.
“We have heard in interviews primarily from hospitals that they have not seen prices really start to drop until after at least two biosimilars are on the market,” she said. “That said, hopefully the entrance of one biosimilar will put pressure on manufacturers to reduce prices.”
Hanauer explained the byzantine process by which biosimilar manufacturers may set the cost of their drugs.
“The purported cost-savings have yet to pertain to patient co-pays that are primarily subsidized by originators and will need to be matched by biosimilars to gain patient buy-ins,” he said. “The biosimilar producers will also need to match originator services, such as nurse advocates, patient assistance and practice assistance plans, to ease the burden or pre- and re-authorizations.”
Bond added that the payor formulary also will play a role in the cost of ustekinumab biosimilars.
“As patients often self-administer the medication, they obtain medication from specialty pharmacies,” she said. “Whether the biosimilar is on a lower — meaning, less expensive — tier relative to the originator will determine whether a patient faces a lower out of pocket price even if the manufacturer price is lower.”
Looking ahead, Bond envisions a future when multiple IL-12/23 inhibitors will be in play, at which point cost savings for patients could truly come to fruition.
“A handful of pharmaceutical companies have ustekinumab biosimilars in the pipeline,” she said. “Although at present there are not as many biosimilar entrants as Humira, ustekinumab is one of the top spending biologic medications in the United States, so more pharmaceutical companies are likely to follow Amgen in trying to bring a biosimilar to market.”
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