On December 3, 2024, Accord BioPharma, Inc. (“Accord”), the U.S. specialty division of Intas Pharmaceuticals, Ltd. (“Intas”), announced an agreement to acquire Coherus BioSciences,…
On December 3, 2024, Accord BioPharma, Inc. (“Accord”), the U.S. specialty division of Intas Pharmaceuticals, Ltd. (“Intas”), announced an agreement to acquire Coherus BioSciences,…
On December 1, 2024, Biocon announced that the FDA has approved YESINTEK™ (ustekinumab-kfce), a biosimilar to J&J’s STELARA®. YESINTEK is approved for the treatment of Crohn’s…
There are four pending BPCIA litigations brought by Amgen against biosimilar companies seeking to market denosumab biosimilars. Two of the four cases are pending in the District Court for the…
On November 13, 2024, Amgen filed a BPCIA complaint in the District Court for the Eastern District of North Carolina against Accord Biopharma, Inc.; Accord Healthcare, Inc.; and Intas…
Daewoong Pharmaceutical announced on October 31 that it has signed a joint sales agreement with Celltrion Pharm to market CT-P41 in Korea. CT-P41, Celltrion’s biosimilar of Amgen’s PROLIA, is…
Alvotech recently submitted a Citizen Petition to the FDA requesting that the agency refuse to license any ustekinumab biosimilar as interchangeable with STELARA if it is manufactured using a…
After the Federal Circuit’s denial last month of Regeneron’s motion for an injunction pending appeal, seeking to prevent Amgen from launching its aflibercept biosimilar, Amgen announced on its…
As we previously reported, on September 24, 2024, the District Court for the Northern District of West Virginia denied Regeneron’s motion seeking a preliminary injunction preventing Amgen from…
On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has…
On October 4, 2024, Amgen filed a BPCIA complaint in the District Court for the Northern District of Illinois Eastern Division against Fresenius Kabi related to Fresenius Kabi’s proposed biosimilar…