Hueston Hennigan Secures Significant Victory for Samsung Bioepis at Third Circuit

Samsung Bioepis is a biopharmaceutical company focused on increasing patient access to high-quality medicines by developing and manufacturing biosimilars. Janssen’s preliminary injunction motion sought to prevent Samsung Bioepis from launching its ustekinumab biosimilar with partner Quallent Pharmaceuticals. The preliminary injunction motion threatened Samsung’s ability to commercialize its biosimilar drug, which treats inflammatory conditions including moderate-to-severe plaque psoriasis and psoriatic arthritis, and put several important commercial relationships for the company at risk.

In April 2025, the Hueston Hennigan team defeated Janssen’s motion at the district court, with the court holding that Janssen had failed to show irreparable harm in the absence of a preliminary injunction. Janssen subsequently appealed to the Third Circuit. While the appeal was pending, in January 2026, the team defeated a second motion for a preliminary injunction brought by Janssen in the district court.

In a unanimous precedential opinion issued on April 14, 2026, the Third Circuit affirmed the district court’s denial of Janssen’s first motion for a preliminary injunction. The court agreed with Samsung Bioepis’s articulation of the standard for showing irreparable harm, and held that Janssen had failed to show that it would suffer such harm.

“We agree with the court’s well-reasoned decision,” said attorney for Samsung Bioepis, Hagan Scotten. “The ruling represents an important win for Samsung Bioepis and its ability to offer its biosimilar drug in the United States.”

In addition to Scotten, the Hueston Hennigan team includes John Hueston, Christine Woodin, Karen Ding, Bram Alden, Chandler Matz and Katie Ross.

The case is Johnson & Johnson et al. v. Samsung Bioepis Co. Ltd., No. 25-1831 (3^rd Cir.) and 25-cv-01439 (D.N.J.).