Yesterday, it was announced that Johnson and Johnson (J&J) had sought a preliminary injunction against Samsung Bioepis to prevent sales of a planned private-label version of Pyzchiva with an undisclosed pharmacy benefit manager (PBM). J&J claimed that the licensing arrangement signed in 2023 with Samsung did not permit sublicensing, as it was referred to in the lawsuit, when it agreed to allow launch of Pyzchiva in February.
The contract was signed in 2023 (before the announcement of CVS Health’s Cordavis agreement with Sandoz for its Hyrimoz biosimilar version of adalimumab); therefore, J&J’s lawyers likely did not account for the specific possibility of private labeling in its contract with Samsung Bioepis or with other biosimilar makers. We contacted Samsung for comment, but they responded that they cannot speak to matters in litigation.
This action also raises the question as to whether or when Amgen will face a similar lawsuit. Amgen and Samsung were the only two ustekinumab biosimilar makers to disclose publicly that were (or had) negotiated private-label manufacturing agreements with a PBM. Amgen launched their product as a private-label biosimilar with Nuvaila in January, under a licensing agreement with J&J that likely has similar stipulations.
In 2022, J&J introduced a nonbranded form of Remicade to compete with the infliximab biosimilars. Since infliximab was not covered under a pharmacy benefit, there has been no opportunity for private labeling. On the other hand, AbbVie did undertake private labeling for its unbranded version of Humira last year, which is covered under the pharmacy benefit by nearly all payers.
In the lawsuit filed by J&J, the company cites AbbVie’s experience first losing some adalimumab market share upon the introduction of the first private-label biosimilar in April 2024. However, Humira did not experience an immediate or dramatic loss of market share with biosimilar introduction. We would also point out that Humira market share declines were far slower than that for most of the biosimilars introduced into the US health care system by that time.
We don’t know the actual stipulations of the licensing arrangement in question. We do know that the marketing exclusivity for Stelara has expired. We do know the principal patents for composition of matter have expired.
The lawsuit cites that Samsung Bioepis’ action will cause “irreparable harm” to J&J. We do know from annual earnings reports that J&J has earned more than $23 billion in net US revenue of Stelara just between 2022 and 2024.
We can also assume that the licensing agreements between J&J and the other biosimilar manufacturers include payment of royalties to the reference manufacturer, as have licensing agreements for biosimilars in the past. We assume that J&J has already begun, encouraging use of its other interleukin product (guselkinumab) instead of Stelara, as AbbVie has done with its own higher-priced autoimmune products.
The lawsuit claims that the undisclosed PBM as part of the agreement 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.” No kidding. That’s what a PBM does.
The feedback I’m receiving from attorneys covering the pharmaceutical arena is that this lawsuit shouldn’t go far. The courts will likely consider the plaintiff’s position less than compelling, considering that some level of market share loss will no doubt occur immediately upon launch of the several branded biosimilars. And, as Amgen has already launched a private-label version of ustekinumab, that horse has already left the barn. Even if Amgen received notification of a legal action this week, it has already been selling its own private-label biosimilar product for over a month.
Apparently, J&J claim of breach of contract does not apply to Samsung Bioepis’ Pyzchiva branded product, or with the full content of the licensing agreement. We’ll find out more details in the coming days, but we hope this does not deter Samsung and its marketing partner Sandoz in their plans to jump start uptake of Pyzchiva brand and the private-label product.
