Johnson & Johnson (J&J) has sued Samsung Bioepis over a ‘concealed plan’ to supply an unnamed health conglomerate with a private label biosimilar version of blockbuster Stelera (ustekinumab).
According to the lawsuit filed on 24 February in New Jersey, J&J alleges that Samsung Bioepis has conducted a “surreptitious and deliberate breach” that “threatens irreparable harm to Janssen” in the time since the existing settlement was reached.
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Developed by subsidiary Janssen, now J&J Innovative Medicine, Stelara has been J&J’s top selling drug since 2019, bringing in peak sales of $11bn in 2023. It is used to treat multiple inflammatory skin and bowel conditions.
J&J has pursued several deals with companies to permit biosimilar launches after Stelara’s patent expired in July 2024. One of those was with Samsung Bioepis in November 2024, allowing it to market a biosimilar to Stelara in February 2025. Samsung Bioepis launched this product, under the brand name Pyzchiva, in the US earlier this week with partner Sandoz.
Despite the contract not permitting Samsung to sub-license its rights for an additional, private label drug, the biosimilar specialist has purportedly done exactly that, according to J&J.
A J&J spokesperson told Pharmaceutical Technology: “Samsung Bioepis is in breach of contract. 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.”
Private labelling is a common practice in the pharmaceutical industry and refers to a manufactured product that is then sold under another company’s brand name, often at a lower price point. However, private-label products are still subject to regulatory standards and proper legal proceedings.
The ‘party’ Samsung has authorised for the additional biosimilar has not been named, described only as a “health conglomerate” that is one of the largest pharmacy chains and health insurers in the US.
J&J is seeking a preliminary and permanent injunction to the private label product, blocking its launch in the US. If the new biosimilar does reach pharmacy shelves, J&J said it would cause “significant diminution of Stelara’s market share and ability to fairly compete”.
The J&J spokesperson added: “The preliminary injunction we are seeking against Samsung Bioepis would not block them from marketing their authorised biosimilar in the US. 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.”
A spokesperson for Samsung Bioepis stated: “We cannot comment on ongoing litigations.”
A Sandoz spokesperson said the company is aware of J&J’s lawsuit against Samsung Bioepsis. “Sandoz is not named as a defendant, and this litigation does not impact the commercialisation by Sandoz of the FDA-approved branded ustekinumab biosimilar Pyzchiva,” the spokesperson added.
The latest court case in the Stelara biosimilar saga once again casts a spotlight on the precarious nature of blockbuster drugs’ market dominance. J&J has been generally successful in reaching settlements with companies planning to launch biosimilars to its flagship drug. US big pharma company Regeneron was not so fortunate with its blockbuster ophthalmic drug Eylea (aflibercept) in a recent case, losing a bid to block a biosimilar developed by Amgen. Regeneron did prevail over Samsung Bioepis, however, winning a preliminary injunction over biosimilar Opuviz until 2027.
Despite attempts by pharma companies to protect market shares, the biosimilar sector is poised for significant growth, according to analysis by GlobalData. Of total sales throughout the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and China), GlobalData forecasts biosimilar sales to increase from 5.7% in 2022 to 18.3% in 2032. This reflects an expansion from $0.5bn to $2.8bn in biosimilar sales over this period.
GlobalData is the parent company of Pharmaceutical Technology.
