Samsung Bioepis allegedly entered into an agreement with a third-party health company, allowing it to market its own private label of a Stelara biosimilar.
Johnson & Johnson on Monday sued Samsung Bioepis, alleging that the South Korean firm had unlawfully authorized a third-party healthcare company to launch a “private label biosimilar” to Stelara, J&J’s IL23-targetting treatment for Crohn’s disease.
The lawsuit, filed in the U.S. District Court of New Jersey and which is heavily redacted, claims that Samsung Bioepis “purported to authorize” this unnamed third company to “market its own private label biosimilar.” In doing so, according to J&J, Samsung Bioepis is in “clear breach” of its agreement with the J&J subsidiary Janssen.
Samsung Bioepis and Janssen signed a settlement deal in November 2023, permitting the entry of the Stelara copycat into the U.S. by Feb. 22, 2025. The biosimilar, dubbed Pyzchiva, launched Monday.
J&J did not name the third-party provider in its complaint, only revealing that it is subsidiary of a “vertically integrated health conglomerate” that includes one of the largest insurers and providers in the U.S. The conglomerate also counts among its members one of the biggest pharmacy chains in the country and a pharmacy benefit manager.
The pharma stated that Samsung Bioepis’ agreement with this conglomerate was a “surreptitious and deliberate breach” of the contract, one that “threatens irreparable harm” to J&J, including the “significant diminution” of Stelara’s market share. Samsung Bioepis’ move, if allowed to push through, could also compromise the ability of Stelara—and other biosimilars—to fairly compete, according to the complaint.
“Janssen has repeatedly made it clear to Samsung its conduct is unlawful,” the complaint read, alleging that the Korean biotech has not even tried to explain or justify its actions. J&J is seeking a preliminary and permanent injunction against the deal between Samsung and its external partner, plus compensatory damages.
Monday’s lawsuit comes as J&J contends with the growing number of Stelara biosimilars entering the U.S. market, threatening to erode the blockbuster drug’s market dominance. Also on Monday—alongside Samsung’s Pyzchiva—Biocon Biologics launched its Stelara biosimilar Yesintek. Ahead of the curve is Amgen, whose Wezlana launched last month and has the FDA’s interchangeability designation, meaning it can be swapped in for the reference product without needing to change the prescription.
There are several others, including Accord BioPharma’s Imuldosa, Teva and Alvotech’s Selarsdi and Celltrion’s Steqeyma.
Anticipating a decline in Stelara sales, J&J has started leaning on its other assets, including the anti-IL23 and anti-CD64 therapy Tremfya, which in September 2024 won the FDA’s approval for severe active ulcerative colitis.
