On March 3, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd., alleging that Accord and Bio-Thera infringe 17 patents in relation to their proposed golimumab biosimilar. Janssen’s complaint was filed under seal, with a redacted version due to be filed on March 11. This is Janssen’s first BPCIA complaint filed concerning a golimumab biosimilar.
On July 16, 2025, Bio-Thera announced that the FDA had accepted its Biologics License Application for its golimumab biosimilar, BAT2506, referencing Janssen’s SIMPONI®. Under the terms of the license and commercialization agreement Bio-Thera entered into with Intas Pharmaceuticals Ltd. in February 2025, Bio-Thera will develop and manufacture BAT2506 while Accord BioPharma, the U.S. specialty division of Intas, will commercialize the biosimilar in the United States.
Stay tuned to Big Molecule Watch for further updates on this BPCIA case.