FDA Approves First Subcutaneous Infliximab Product - Center for …
网页2023年10月23日 · 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 …
FDA Approves Avzivi, the Fifth Biosimilar to Avastin
网页2023年12月19日 · Avzivi was approved with 7 oncology indications. The FDA has approved the fifth bevacizumab biosimilar, Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn) for the treatment of several types of cancer. Avzivi is a humanized monoclonal antibody that inhibits vascular endothelial growth factor and references Genentech’s Avastin (bevacizumab).
FDA Approves Sandoz's Pegfilgrastim Biosimilar, Ziextenzo
网页2019年11月5日 · Article. 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.
Canada Approves High-Concentration Humira Biosimilar
网页2023年1月3日 · 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 Fifth Pegfilgrastim Biosimilar, Fylnetra
网页2022年6月1日 · 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 developed by Amneal Pharmaceuticals ...
FDA Approves Epysqli as Second Soliris Biosimilar - Center for …
网页2024年7月22日 · The approval marked the second for an eculizumab biosimilar, following the May 2024 approval of Bkemv (eculizumab-aeeb). 2 Epysqli is also the eighth US biosimilar approval for Samsung Bioepis, following biosimilars for etanercept, infliximab, adalimumab, trastuzumab, bevacizumab, ranibizumab, aflibercept, and ustekinumab. 3 “The FDA approval of Epysqli as a biosimilar to Soliris marks an ...
Ahzantive Receives FDA Approval as New Eylea Biosimilar
网页July 1, 2024. By Skylar Jeremias. News. Article. The FDA has approved Ahzantive (aflibercept-mrbb) as the third biosimilar referencing Eylea (aflibercept) for the treatment of eye conditions, including age-related macular degeneration. Formycon and its licensing partner Klinge Biopharma announced the FDA approval for Ahzantive (aflibercept-mrbb ...
Biogen, Xbrane Enter Commercialization Agreement for Cimzia …
网页2022年2月10日 · Biogen and Xbrane Biopharma have entered into a commercialization and license agreement for a biosimilar candidate referencing Cimzia (UCB; certolizumab pegol), Xcimzane, for the treatment of rheumatologic conditions. Xcimzane is a monoclonal antibody in preclinical development phases. The reference product’s primary indication is for ...
Center for Biosimilars®
网页September 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.
FDA Approves Samsung Bioepis’ Pyzchiva, a Biosimilar to Stelara
网页2024年7月1日 · The FDA approved Pyzchiva based on comprehensive evidence, including analytical, nonclinical, and clinical data, confirming its biosimilarity to Stelara with no significant differences in safety, purity, or potency. A phase 1 study (NCT04772274) showed equivalent pharmacokinetics, safety, tolerability, and …