On October 26, 2023, Genentech, a member of the Roche Group, announced that the FDA approved VABYSMO (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the third indication approved for VABYSMO, in addition to wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular…
On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA. As we covered previously, Janssen and Amgen settled their BPCIA litigation regarding Amgen’s ustekinumab biosimilar product in May 2023….
On October 27, Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. announced that the U.S. Food and Drug Administration approved LOQTORZI (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment…
The Cellular, Tissue, and Gene Therapies Advisory Committee of the FDA is meeting tomorrow, Tuesday, October 31, 2023, to review a Biologics License Application by Vertex Pharmaceuticals Inc. for exagamglogene autotemcel (exa-cel). Exa-cel is a cell-based gene therapy product composed of the patient’s own hematopoietic stem and progenitor cells (HSPCs) edited…
On October 23, 2023, Celltrion announced FDA approval for ZYMFENTRA (infliximab-dyyb), a subcutaneous formulation for maintenance therapy for patients with moderately to severely active ulcerative colitis and Crohn’s disease. Infliximab is a TNF blocking agent that was first approved by the FDA as an intravenous formulation for the treatment of…
As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts, asserting that Biogen sought FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra®…
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…
Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the development of individualized cellular and gene therapies (CGTs).” Individualized CGTs are therapies “developed for a single patient (or a very small…
On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM’s.” According to the press release, YUFLYMA (adalimumab-aaty) will be a…
Meitheal Pharmaceuticals, Inc. (“Meitheal”) has entered into an exclusive licensing deal with Tonghua Dongbao Pharmaceutical Co., Ltd. (“THDB”) to market three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the United States. The agreement grants Meitheal and its parent company, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (“NKF”), exclusive…