We are pleased to present our Year-End Tool Kit, which is intended to assist you in preparing for the upcoming annual reporting and proxy season. Our annual Tool Kit includes updated D&O Questionnaires, executive compensation materials and detailed calendars
Goodwin Procter Blogs
Latest from Goodwin Procter
Update on Pending Denosumab BPCIA Litigations
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 District of New Jersey before Judge O’Hearn: Amgen Inc. et
European Commission Approves Samsung Bioepis and Biogen’s Aflibercept Biosimilar
On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ. Referencing Regeneron’s biosimilar product EYLEA, OPUVIZ is a 40 mg/mL solution for injection, approved for the treatment of neovascular age related macular
FDA approves CAR-T Cell Therapy for Refractory B-cell Precursor Acute Lymphoblastic Leukemia
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
Amgen Files BPCIA Complaint Against Accord Biopharma Regarding Denosumab Biosimilar
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
Celltrion Launches STEQEYMA (ustekinumab) in Germany and the Netherlands
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
FDA Accepts BLA for Shanghai Henlius Biotech’s and Organon’s HLX14, a Denosumab Biosimilar
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
Daewoong and Celltrion to Market Denosumab Biosimilar in Korea
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.
EMA Accepts Marketing Authorization Application for Alvotech’s AVT05 (golimumab)
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
Alvotech Requests that FDA Refuse to License CHO-Cell Derived Ustekinumab Biosimilars as Interchangeable Until the Effects of Sialylation Are Evaluated
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