On October 30, 2024, Shanghai Henlius Biotech and Organon announced that the FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to PROLIA/XGEVA (denosumab). In 2022, Shanghai Henlius Biotech granted Organon exclusive commercialization rights for HLX14 in the U.S., EU, and Canada. The filing for HLX14…
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 of Amgen’s PROLIA and XGEVA. This is the fourth BPCIA litigation regarding denosumab, following Amgen’s litigations against Sandoz, Celltrion, and…
On August 12, 2024, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics related to Samsung Bioepis’s proposed biosimilar of Amgen’s PROLIA and XGEVA. This is the third BPCIA litigation regarding denosumab, following Amgen’s litigations against Sandoz and Celltrion,…
On May 28, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Celltrion related to its denosumab biosimilar of Amgen’s PROLIA and XGEVA. This is the second BPCIA litigation regarding denosumab, following Amgen’s earlier litigation against Sandoz. Amgen and Sandoz stipulated to dismiss…
On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar. Denosumab, sold by Amgen under the brand names PROLIA and XGEVA, is indicated for the treatment of various diseases including osteoporosis…
As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and XGEVA (“the Sandoz Denosumab Litigation”). The FDA subsequently, in March 2024, approved Sandoz’s denosumab biosimilars, WYOST (denosumab-bbdz) and JUBBONTI (denosumab-bbdz), as…
On March 5, Sandoz announced that the FDA approved its denosumab biosimilars, WYOST and JUBBONTI, as interchangeable with Amgen’s XGEVA and PROLIA. These are the first and only FDA-approved denosumab biosimilars. Denosumab is indicated for bone metastasis from various forms of cancer and for the prevention of bone pain and fractures,…
Celltrion Submits Denosumab BLA to FDA: On November 30, 2023, it was reported that Celltrion had completed submission of its application to the FDA for CT-P41, its denosumab biosimilar of Amgen’s PROLIA and XGEVA. According to the report, once CT-P41 is approved in the U.S., “it is expected to secure…
On October 12, Amneal announced that it will be adding two denosumab biosimilars to its oncology pipeline, referencing PROLIA and XGEVA. Denosumab is indicated for bone metastasis from various forms of cancer and for the prevention of bone pain and fractures, including osteoporosis-related injuries. Amneal announced that mAbxience will develop…
On May 1, 2023, Amgen filed a BPCIA complaint in the District of New Jersey against Sandoz related to Sandoz’s denosumab biosimilar of Amgen’s PROLIA® and XGEVA®. This is Amgen’s first BPCIA case filed with respect to a denosumab biosimilar. According to Amgen, PROLIA is “prescribed to treat patients with…