There have been several recent developments in the PTAB with respect to Regeneron’s aflibercept-dosing patents. On July 8, Regeneron voluntarily dismissed its appeals to the Federal Circuit (Case Nos. 2023-1395 and 2023-1396) of six IPR final written decisions, finding claims of U.S. Patent Nos. 9,669,069 and 9,254,338 unpatentable. The IPRs…
On August 12, 2024, Sandoz announced that the FDA has approved ENVEEZUTM (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. ENVEEZUTM is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). According to Sandoz, the FDA also “provisionally determined that ENVEEZUTM would be interchangeable with…
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,…
The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024. Notably, the committee adopted positive opinions for the following 6 biosimilar products: Samsung Bioepis’s EKSUNBI (ustekinumab), Formycon AG’s FYMSKINA (ustekinumab), and Fresenius…
Samsung Bioepis (“Samsung”) announced on July 22 that the FDA approved its BLA for EPYSQLI, an eculizumab biosmilar referencing Alexion’s SOLIRIS. EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. After…
Samsung Bioepis’ PYZCHIVA On July 1, Samsung Bioepis Co., Ltd. announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). PYZCHIVA is approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active…
As we previously reported, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) sued Samsung Bioepis Co. Ltd. (“Samsung”) in January 2024 in the U.S. District Court for the District of Delaware, alleging infringement of six patents under the BPCIA based on Samsung’s submission of its BLA for…
FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s YESAFILI (aflibercept-jbvf) and Samsung…
As we previously reported, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) sued Samsung Bioepis Co. Ltd. (“Samsung”) in January 2024 in the U.S. District Court for the District of Delaware. Alexion’s complaint alleged infringement of six patents under the BPCIA based on Samsung’s submission of its…
As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation. Pursuant to that order, Regeneron’s case against Amgen, Inc. (“Amgen”) was transferred from the Central District of California to the Northern District of…