J&J Sues Samsung Bioepis Over Biosimilar Breach
Johnson & Johnson (J&J) has filed a lawsuit against Samsung Bioepis, alleging a breach of their 2023 agreement concerning the launch of Pyzchiva, a biosimilar to J&J's Stelara. The dispute centers on Samsung's attempt to sublicense Pyzchiva to a private-label distributor, a move J&J contends violates their settlement terms. J&J is seeking a preliminary injunction to prevent U.S. sales of the private-label version.
The following article originally appeared in Fierce Pharma.
As Stelara biosimilars gradually make their way on to the U.S. market, Johnson & Johnson has accused one early adopter—Samsung Bioepis—of violating the settlement that paved the way for the launch of its biologic copycat earlier this week.
Johnson & Johnson on Monday filed a lawsuit against Samsung Bioepis in a New Jersey federal court, accusing the Korean company of breaching its contract by attempting to sublicense a second biosimilar on top of the product it’s allowed to launch under a 2023 settlement with J&J.
The legal update comes after Samsung Bioepis and its commercialization partner Sandoz on Monday announced the U.S. launch of their authorized Stelara biosimilar, Pyzchiva.
Under a settlement inked with J&J in late 2023, Samsung Bioepis and Sandoz got the all-clear to launch their Stelara biosimilar from Feb. 22, 2025. The settlement is one of many J&J has inked over the years in a bid to manage the loss of exclusivity on one of its most prominent blockbusters.
Samsung Bioepis did not immediately respond to Fierce Pharma’s request for comment on the new J&J lawsuit.
The issue isn’t that Samsung Bioepis is selling its own Stelara biosimilar, according to J&J. Rather, the New Jersey drug giant is taking issue with Samsung Bioepis' move to sublicense "a second, additional product" to a pharmacy benefit manager's private label distributor, a J&J spokesperson explained in a statement.
The distributor, which isn’t named in J&J’s lawsuit, aims to launch its private label biosimilar early this year, according to the lawsuit.
J&J argued in its lawsuit that the unnamed distributor has the “means, motive, and opportunity to steer its patients, the customers of its pharmacies, and the insurance companies it selects drugs for toward [the] private label drug and thereby disadvantage or exclude Stelara (and other biosimilars) from its formularies.”
In light of the alleged violation, J&J is seeking a preliminary injunction against Samsung Bioepis, plus damages, though it isn’t trying to stop the drugmaker from marketing its authorized biosimilar, Pyzchiva, in the U.S.
J&J has been bracing for the entry of Stelara biosimilars for years now. Biologic copycats of the popular immunology drug first cropped up in Europe last summer, beginning with Alvotech and Stada’s Uzpruvo, though patent litigation delayed the arrival of Stelara biosims in the U.S. until the beginning of this year.
Stateside, Amgen’s biosimilar Wezlana debuted Jan. 1, marking the initial arrival of Stelara knockoffs in the U.S. That launch was followed by the rollout of Teva and Alvotech’s Selarsdi on Friday and now, Samsung Bioepis and Sandoz’s Pyzchiva.
Despite the biosimilar threat, J&J seems relatively confident in its ability to navigate beyond Stelara’s patent cliff, with executives noting on an earnings call last month that the pivot away from Stelara could drive patients toward newer immunology offerings like J&J’s own Tremfya.
In terms of how Stelara’s loss of exclusivity is likely to play out, “we’ve talked about the Humira erosion curve being probably the best thing to model,” Jennifer Taubert, J&J’s worldwide chairman of innovative medicines, said last month, referencing the situation that has played out with AbbVie’s Humira and its newer IL-23 inhibitor Skyrizi following the arrival of adalimumab biosimilars.
Still, J&J is already feeling the sales pressure from off-brand Stelara launches overseas.
Overall, global Stelara sales dropped 14.7% year over year to roughly $2.3 billion in 2024’s fourth quarter. For the full 12-month earnings period, Stelara sales slipped around 4.6% to $10.4 billion, J&J reported last month.
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