First Rituximab Biosimilar, Truxima, Launches in the United States
WEBNov 7, 2019 · Teva and Celltrion have announced the launch of their biosimilar rituximab, Truxima, in the United States. The product is being offered at a 10% discount to the list price of reference product, Rituxan. The product will begin to reach patients on November 11. Truxima will be available at $845.55 for a 100-mg vial and $4227.75 for a 500-mg vial ...
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 ...
Canada Approves High-Concentration Humira Biosimilar
WEBJan 3, 2023 · Samsung Bioepis announced the Canadian approval of its high-concentration (HC), citrate-free formulation of its biosimilar referencing Humira (adalimumab). Hadlima HC was developed through a commercialization agreement between Samsung Bioepis and Organon. The approval comes almost 4 years after Health Canada’s initial approval of the low-concentration version of Hadlima (SB5) in May 2018.
FDA Approves Sandoz's Pegfilgrastim Biosimilar, Ziextenzo
WEBNov 5, 2019 · The FDA has approved Ziextenzo (pegfilgrastim-bmez), Sandoz’s biosimilar pegfilgrastim referencing Neulasta. The biosimilar was approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer treatment. Sandoz plans to launch the product this year.
CVS Launches New Biosimilars Brand - Center for Biosimilars
WEBSep 6, 2023 · CVS Health Corporation announced that it is launching a new subsidiary (Cordavis), which will work directly with manufacturers to commercialize and coproduce biosimilars. “As the U.S. pharmaceutical environment continues to evolve, biosimilars represent one of the biggest opportunities for reducing drug costs for …
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 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 …
Center for Biosimilars®
WEBSeptember 24th 2024. Part 2 of our series diving into the Association for Accessible Medicines' (AAM) latest report discusses that while generics and biosimilars saved $445 billion in 2023, their potential is hindered by high patient costs, drug shortages, and ineffective policies, underscoring the need for reforms to fully realize their benefits.
What Amgen’s Biosimilar Trends Report Says About the Future of …
WEBNov 27, 2022 · The report also gave insight into how biosimilar policies, such as reimbursement structures, could develop in the future and whether the United States is heading towards greater biosimilar adoption. On this episode, I’m joined by Chad Pettit, the executive director of marketing and global biosimilars commercial lead at Amgen.