FDA Approves Pfizer's Rituximab Biosimilar, Ruxience
WEBJul 23, 2019 · This article has been updated. The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis. The fact that …
FDA Approves Semglee Insulin Glargine as First Interchangeable …
WEBJul 29, 2021 · The FDA has approved Biocon Biologic's Semglee insulin glargine as an interchangeable biosimilar, referencing Lantus. The approval carries with it many hopes for stronger competition in the insulin market, which is dominated by a handful of brands and characterized by stubbornly high prices. The approval of Semglee was much anticipated; it …
Festival of Biologics - Center for Biosimilars
WEBMarch 22nd 2023. At the Festival of Biologics, Hillel Cohen, the executive director of scientific affairs at Sandoz, shared the current body of literature on biosimilar-to-biosimilar switching, saying that although there isn’t much published data, the vast real-world experience demonstrates the safety of this type of medication switch.
FDA Approves First Subcutaneous Infliximab Product - Center for …
WEBOct 23, 2023 · The FDA approved Celltrion USA’s Zymfentra (infliximab-dyyb), the world’s first and only subcutaneous infliximab product. Zymfentra is approved as a novel drug, and its development is based on Remicade (reference intravenous infliximab). The intravenous version of Zymfentra is marketed as Inflectra (also, infliximab-dyyb), Celltrion's ...
FDA Approves Stimufend, the US’ Sixth Pegfilgrastim Biosimilar
WEBSeptember 6, 2022. By Skylar Jeremias. Article. Fresenius Kabi announced the FDA approval of its pegfilgrastim biosimilar referencing Neulasta, making it the sixth pegfilgrastim biosimilar to be approved in the United States. The FDA has approved Stimufend (pegfilgrastim-fpgk), a biosimilar referencing Neulasta, according to a statement from ...
Eli Lilly Launching Lower-Priced Authorized Generic of Its Insulin …
WEBMar 4, 2019 · Eli Lilly and Company said Monday it is introducing a lower-priced authorized generic of its insulin lispro injection (Humalog) in the United States. The generic will have a list price 50% lower than the current Humalog list price. The price of insulin has been top-of-mind for many lawmakers from both sides of the aisle, starting with a Senate ...
FDA Approves Fifth Pegfilgrastim Biosimilar, Fylnetra
WEBJun 1, 2022 · The FDA approved Fylnetra, the fifth approval for a pegfilgrastim biosimilar in the United States. The FDA has approved the fifth pegfilgrastim biosimilar for the US market, Amneal Pharmaceuticals and Kashiv Biosciences’ Fylnetra (pegfilgrastim-pbbk), referencing Neulasta. Fylnetra is the third biosimilar …
FDA Approves First Denosumab Biosimilars - Center for Biosimilars
WEBMar 5, 2024 · The FDA has approved Wyost/Jubbonti (denosumab-bddz; GP2411), the first biosimilar to reference Xgeva/Prolia (denosumab) in the US. 1 The drugs will be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.. The FDA accepted Sandoz’ biologics license application for Wyost/Jubbonti in February 2023.
FDA Approves Autoinjector Version of Neulasta Biosimilar
WEBMar 6, 2023 · The original version of Udenyca was approved in November 2018 and launched on the US market in January 2019. It is 1 of 6 FDA-approved biosimilars referencing Amgen’s Neulasta. In addition to the 2 FDA-approved presentations for the biosimilar, another application for an on-body injector version is under review.
FDA Approves First Eylea Biosimilars - Center for Biosimilars
WEBMay 20, 2024 · The FDA announced that it approved the first 2 biosimilars referencing Eylea (aflibercept) for the treatment of ophthalmic conditions, including neovascular age-related macular degeneration (AMD), macular edema, and diabetic retinopathy.. Biocon Biologics's Yesafili (aflibercept-jbvf) and Samsung Bioepis' Opuviz (aflibercept-yszy) are vascular endothelial growth factor (VEGF) inhibitors that ...