Court Halted Sale of Accord Biosimilar Drug
A federal court blocked the launch of BAT2506 while patent litigation between Janssen and the manufacturers proceeds.
Updated on Oct. 6, 2026 in Biotech
The U.S. District Court for the District of Delaware issued a preliminary injunction on September 30, 2026, prohibiting Accord BioPharma and Bio-Thera Solutions from manufacturing or selling their golimumab biosimilar, BAT2506. The order requires Janssen Biotech to post a $98.8 million bond.
Why it matters
The injunction creates a temporary barrier to market entry for the biosimilar while the court evaluates a complex set of 17 patents. This ruling directly impacts the competitive landscape for immunology treatments in the United States.
Janssen is currently asserting 17 patents against the defendants, while the U.S. Patent and Trademark Office has moved forward with four inter partes review proceedings—a legal process to challenge patent validity—as of September 9, 2026.
The players
Janssen Biotech
A pharmaceutical subsidiary of Johnson & Johnson that develops immunology and oncology biologics.
Accord BioPharma
A division of Intas Pharmaceuticals focused on bringing biosimilar and specialty medicines to the U.S. market.
Bio-Thera Solutions
A Guangzhou-based biotechnology firm specializing in the development of monoclonal antibody biosimilars.
The details
The court order effectively freezes the commercial trajectory of BAT2506, a biosimilar—a follow-on version of a biologic drug that is highly similar to the original product but not identical—intended to treat autoimmune conditions. This litigation centers on whether the defendants' manufacturing process and product formulation infringe upon the 17 patents held by Janssen. The case is now proceeding under number 1:26-cv-00222 in Delaware federal court.
Timeline
March 3, 2026: Janssen filed the initial complaint against the defendants.
September 9, 2026: The USPTO granted institution in four inter partes review proceedings.
September 30, 2026: The court issued the preliminary injunction order.
The Tech Race
The litigation highlights the ongoing battle between originator biologics and biosimilar developers seeking to capture market share through high-cost, multi-patent disputes. This case follows the standard procedural pattern established by the Hatch-Waxman Act for resolving drug patent disputes.
Patients and healthcare providers will not see the expected market entry of the BAT2506 biosimilar while this injunction remains in effect. The timing for when or if the product will become available is currently unknown due to the ongoing litigation.
The takeaway
This injunction demonstrates how patent litigation can delay the introduction of lower-cost biosimilar alternatives for patients. Interested observers should monitor the outcomes of the four ongoing inter partes review proceedings for signals on the potential long-term validity of the contested patents.
Further reading
For broader trends in pharmaceutical patent disputes and market competition, visit our Biotech section.
