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 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 (also, infliximab-dyyb), …
Despite Steep Discounts, Humira Biosimilars Are Priced More Than ...
网页2023年7月17日 · Throughout 2023, 9 FDA-approved adalimumab biosimilars are projected to enter the US market. As of the second week of July 2023, 8 had entered the market, beginning with Amgen’s Amjevita (adalimumab-atto) in January. Amjevita launched with a dual price strategy, where 2 versions of the drug would launch at 2 different prices (5% …
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 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 immunogenicity between Pyzchiva …
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 ...
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 …
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 ...
FDA Approves First Stelara Biosimilar, Wezlana - Center for …
网页2023年11月1日 · The FDA approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference Stelara (ustekinumab). The biosimilar was also approved with an interchangeability designation. Stelara is an interleukin-12 and interleukin-23 antagonist used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, and …
FDA Approves High-Concentration Cyltezo - Center for Biosimilars
网页2024年5月1日 · The FDA approved a high-concentration, citrate-free version of Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), making it the fifth high-concentration biosimilar referencing Humira (adalimumab) to be approved in the US. Image credit: gustavofrazao - stock.adobe.com. “With this FDA approval, we are now able to offer both high- and low ...