On November 8, 2024 Autolus, Inc. (“Autolus”) announced that the FDA has approved AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”). AUCATZYL is a CAR T cell therapy designed to specifically recognize and bind CD19-positive B-cells in precursor ALL…
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 Pharmaceuticals, Ltd., related to Accord’s proposed biosimilar of Amgen’s PROLIA and XGEVA. This is the fifth BPCIA litigation regarding denosumab, following Amgen’s litigations…
As we previously reported, this August the European Commission granted approval for Celltrion’s STELARA biosimilar, STEQEYMA. Earlier this month, Celltrion launched STEQEYMA in both Germany and the Netherlands. Celltrion also plans to launch STEQEYMA in Finland in mid-November, and in Ireland later in the month. STEQEYMA is the third ustekinumab…
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…
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 scheduled to launch in Korea in the first half of 2025. Under the agreement, Daewoong and Celltrion will jointly promote CT-P41…
On November 4, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s biosimilar to Simponi® (golimumab), for the treatment of several chronic inflammatory diseases. The announcement “is believed to be the first marketing authorization application filing announced globally…
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 Chinese hamster ovary (“CHO”) cell line—and in particular Samsung Bioepis’s PYZCHIVA (ustekinumab-ttwe). Alvotech stated that “unless and until the Agency has…
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 Q3 earnings call last week that it has launched its aflibercept biosimilar, PAVBLU. On the call, Murdo Gordon, Amgen’s Executive Vice President of…
On October 22, 2024, Alvotech and Teva announced that SELARSDI™ (ustekinumab-aekn) received FDA approval for a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. We previously reported that SELARSDI™ was approved by the FDA for 45 mg/0.5 mL and 90 mg/mL in a single-dose…
On October 9, 2024, Bio-Thera Solutions and Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to STELARA (ustekinumab). Under the agreement, Bio-Thera will be responsible for development, manufacturing, and supply of BAT2206, and Richter will have exclusive rights to commercialize the…