- in European Union
On April 28, the U.S. District Court for the District of New Jersey denied Janssen Biotech, Inc. ("Janssen") and Johnson & Johnson's motion for a preliminary injunction seeking to enjoin Samsung Bioepis Co. Ltd. ("Samsung") from launching a private label biosimilar of Janssen's STELARA® (ustekinumab) in a breach of contract case. The court's opinion is currently under seal.
As we previously reported, on November 30, 2023, Janssen and Samsung settled the BPCIA litigation over Samsung's ustekinumab biosimilar. Under the terms of the settlement agreement, the license period began on February 22, 2025. Samsung's PYZCHIVA® (ustekinumab-ttwe) was approved by the FDA on July 1, 2024. On February 24, 2025, Samsung and its commercial partner launched PYZCHIVA® in the United States.
In their complaint filed on February 24, 2025, Janssen and J&J alleged that Samsung breached the licensing agreement when they announced their intent to launch a private label biosimilar to STELARA®. Janssen and J&J claimed that the alleged breach would cause irreparable harm to Janssen's market share and ability to fairly compete.
Janssen and J&J have appealed the district court's decision to the U.S. Court of Appeals for the Third Circuit.
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