FDA Approves First Subcutaneous Infliximab Product - Center for …
Oct 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).
FDA Approves Samsung Bioepis' Etanercept Biosimilar, Eticovo
Apr 26, 2019 · This story has been updated. The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). Before the FDA announced this development, a representative from Samsung Bioepis confirmed approval of the product to The Center for Biosimilars ® in an email.. The biosimilar was approved to treat all indications of its reference, Enbrel: rheumatoid arthritis (RA ...
FDA Approves First Biosimilar for Neulasta Onpro - Center for …
Jan 15, 2024 · Coherus Biosciences has announced that the FDA has approved its on-body injector version of Udenyca (pegfilgrastim-cbqv) as biosimilar to Neulasta Onpro (pegfilgrastim with on-body injector). “Our market studies showed a significant demand for a novel on-body pegfilgrastim delivery device tailored to specific patient needs.
FDA Approves Pfizer's Rituximab Biosimilar, Ruxience
Jul 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 …
FDA Approves First Eylea Biosimilars - Center for Biosimilars
May 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 ...
FDA Approves Amgen's Trastuzumab Biosimilar, Kanjinti
Jun 13, 2019 · The FDA has approved Amgen’s ABP 980, a trastuzumab biosimilar referencing Herceptin. The drug, trastuzumab-anns, will be sold as Kanjinti. Kanjinti was approved for the treatment of HER2-positive breast cancer and gastric cancer.. The news of the approval comes just a week after the 2019 American Society of Clinical Oncology Annual Meeting, where researchers reported new safety data from ...
FDA Approves Stimufend, the US’ Sixth Pegfilgrastim Biosimilar
Sep 6, 2022 · The FDA has approved Stimufend (pegfilgrastim-fpgk), a biosimilar referencing Neulasta, according to a statement from the developer, Fresenius Kabi. The biosimilar marks the sixth pegfilgrastim biosimilar to receive regulatory approval.
FDA Approves Imuldosa, a Biosimilar to Stelara
Oct 11, 2024 · Stelara is one of the highest-grossing biologics in the US, generating $10.86 billion globally in 2023. Additionally, US sales for Stelara reached $6.4 billion in 2022, according to Johnson & Johnson's annual financial report.It’s also 1 of the first 10 medications selected by CMS for drug price negotiation, which will go into effect at the start of 2026.
FDA Approves First Stelara Biosimilar, Wezlana - Center for …
Nov 1, 2023 · The FDA approved Wezlana (ustekinumab-auub), making it the first approval for a biosimilar referencing blockbuster drug Stelara (ustekinumab). The agency also granted Wezlana an interchangeability designation.
FDA Approves First Denosumab Biosimilars - Center for Biosimilars
Mar 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.