Sandoz Launches Pyzchiva as Manufacturer Samsung Is Sued by J&J

While the “Big Three” PBMs’ private-label subsidiaries have drawn recent attention for their agreements with pharma companies to offer their own branded biosimilars, one of these planned arrangements has landed a manufacturer in hot water.

Johnson & Johnson and its Janssen Biotech, Inc. subsidiary — now known as Johnson & Johnson Innovative Medicine — on Feb. 24 filed a lawsuit (Case 2:25-cv-01439) against Samsung Bioepis Co. Ltd. over its attempts to sell a private-label biosimilar of J&J’s interleukin-12/IL-23 antagonist Stelara (ustekinumab) via an unidentified PBM private-label subsidiary in addition to Samsung’s Pyzchiva (ustekinumab-ttwe) biosimilar.

According to a patent litigation settlement unveiled by Samsung on Nov. 30, 2023, the manufacturer was allowed to launch SB17 (now known as Pyzchiva) on Feb. 22, 2025, amid several other competitors. The FDA approved Pyzchiva on June 28, 2024.

Sandoz is commercializing the biosimilar, and on Feb. 24, the company revealed that it had launched Pyzchiva. J&J filed its lawsuit against Samsung on the same day.

The lawsuit — which is highly redacted — claims that “on or about” Dec. 10, 2024, Samsung informed the plaintiffs that “it had purported to authorize” the private-label subsidiary of an unidentified PBM “the right to market its own private label biosimilar…‘early’ in 2025.”

This private-label biosimilar would be in addition to Pyzchiva.

Launching an extra biosimilar, claims J&J, is “in clear breach of the [patent litigation] Agreement,” which “does not permit Samsung to authorize [redacted] to introduce an additional, private label drug at the expense of Janssen’s market share and fair competition.”

J&J describes the company with whom Sandoz has the arrangement as a “vertically integrated health conglomerate that includes (i) the largest health insurer in the United States, (ii) one of the largest health care providers in the United States, (iii) one of the largest pharmacy chains in the United States, and (iv) a pharmacy benefits manager (“PBM”).”

The top three PBMs — CVS Health Corp.’s Caremark, The Cigna Group’s Express Scripts and UnitedHealth Group’s Optum Rx — all have private-label subsidiaries: CVS unveiled Cordavis in 2023; Cigna launched Quallent Pharmaceuticals in 2021; and UnitedHealth’s Nuvaila debuted earlier this year with the first Stelara biosimilar, Amgen Inc.’s Wezlana (ustekinumab-auub), which launched Jan. 1 with Nuvaila as the sole distributor.

Among vertically integrated health conglomerates, “the playbook common[ly]…calls for a private label distributor to obtain the generic or biosimilar drugs from a manufacturer, brand the generics or biosimilars with its name, increase their prices far above wholesale acquisition cost, and then steer patients it treats, patients it insures, and other insurance groups that use its PBM services, to purchase its private label from the specialty pharmacies it owns,” explains the lawsuit.

It then cites Federal Trade Commission (FTC) research that “in a single year, [redacted] oligopoly reaped over $7.3 billion in profit from this strategy.” In its January 2025 second interim staff report on PBMs, the agency found that from 2017 to 2022, the Big Three PBMs generated more than $7.3 billion from marking up specialty generic drugs sold at their affiliated pharmacies by hundreds and thousands of percent.

J&J: Offering Will ‘Disadvantage’ Stelara From Formularies

J&J claims that Samsung has been “concealing its plans” around the “surreptitious and deliberate breach” of the companies’ agreement. Since December, says J&J, it has “repeatedly made clear to Samsung its conduct is unlawful” and that it would pursue legal remedy if the defendant did not turn over various unredacted agreements.

By offering private-label biosimilars, the subsidiary is “disadvantag[ing] or exclud[ing]” Stelara (and other biosimilars) from its formularies,” alleges the lawsuit. “This is no abstract hypothetical risk, but exactly what [redacted] has previously effectuated through analogous private label arrangements,” and it “threatens irreparable harm, including significant diminution” of the reference drug’s market share and its ability to compete fairly.

As an example, the lawsuit points to Cordavis’ agreement with Sandoz to offer Cordavis-branded biosimilar Hyrimoz (adalimumab-adaz); remove its reference drug, AbbVie Inc.’s Humira (adalimumab), from its national commercial template formularies; and offer the originator drug via an agreement for it to be sold as Cordavis-branded Humira.

Within a month, says the lawsuit, Cordavis gained 22% of the adalimumab market, a “staggering erosion of molecule share” from Humira. J&J says it expects the same thing to happen with Stelara due to Samsung’s “breach of the Agreement.”

This is J&J’s concern, says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates: “That, as exemplified by Humira and its biosimilars, a market-dominant PBM demonstrated its ability to quickly move market share to its preferred private-labeled biosimilar, while excluding from the formulary nonpreferred competing biosimilars as well as the reference brand. The latter is the ‘irreparable harm to Janssen’ that is alleged, which ‘includes the loss of market share, particularly due to the potential for <the named PBM> to block access to its own ecosystem.’”

When the FDA approved Pyzchiva, it granted the agent provisional interchangeability due to an “unexpired period of exclusivity for the first interchangeable biosimilar,” which is Wezlana. In the press release unveiling Pyzchiva’s launch, Samsung stated that its biosimilar “is expected to offer interchangeability in the first half of 2025.”

In early September 2024, Cigna’s Evernorth Health Services revealed plans to offer an interchangeable biosimilar of Stelara for $0 for “eligible patients” of its specialty pharmacy, Accredo, starting “early next year.” The agent will be produced by Quallent. The biosimilar’s price, it said, will be more than 80% less than Stelara’s list price.

Cordavis has yet to make public its plans for a Stelara biosimilar.

“We support biosimilar competition and we have in good faith entered into multiple early entry agreements that will allow up to seven ustekinumab biosimilars to launch in the U.S. this year,” says J&J in a statement.

“We have an early entry agreement with Samsung Bioepis to enable the introduction of an ustekinumab biosimilar earlier than our STELARA® patent expiry. The agreement allows Samsung Bioepis to launch its own biosimilar independently or through a commercialization partner, but not further assign or sub-license these rights to other parties,” says the drugmaker. “Indeed, Samsung and Sandoz announced the launch of Pyzchiva on February 24. This litigation does not seek to prevent Samsung from selling that product, but instead to prevent it from improperly sublicensing a second, additional product to a Pharmacy Benefit Manager (PBM)’s private label distributor.

“Samsung Bioepis is in breach of contract,” continues J&J. “After numerous attempts to resolve Samsung Bioepis’ breach of our settlement agreement, we have brought a complaint against Samsung Bioepis to enforce the terms of our early entry agreement.”

The reference drug manufacturer notes that “the preliminary injunction we are seeking against Samsung Bioepis would not block them from marketing their authorized biosimilar in the U.S. Rather, our complaint against Samsung Bioepis relates to their breach of the contract in attempting to license a second biosimilar, which is prohibited by their agreement with us, and nonadherence to the agreement terms.”

This article was reprinted from AIS Health’s monthly publication Radar on Specialty Pharmacy.