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The first biosimilar of a monoclonal antibody to be approved worldwide was a biosimilar of infliximab in the EU in 2013. [9] On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz.
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
The Food and Drug Administration approved two interchangeable biosimilars to Eylea (aflibercept), a brand name drug used to treat age-related macular degeneration, diabetic retinopathy and other ...
In November 2019, adalimumab-afzb (Abrilada) was approved in the United States. [5] [103] [118] [119] [120] It is the 25th biosimilar approved by the FDA. [121] In February 2020, the biosimilar Amsparity was approved for use in the European Union. [13] In June 2020, the biosimilar Idacio was approved for use in Australia. [37]
The agency approved Biocon Biologics' Yesafili as well as Samsung Bioepis and Biogen's Opuviz, while also allowing interchangeability, or the drug's substitution with biosimilars without the need ...
The FDA has generally recommended switching studies to show evidence of interchangeability of a biosimilar. Regulatory reform is needed so patients can more easily access biosimilars and draw ...
Alipogene tiparvovec (Glybera): AAV-based treatment for lipoprotein lipase deficiency (no longer commercially available); Axicabtagene ciloleucel (Yescarta): treatment for large B-cell lymphoma [1]
According to the data, FDA-approved biosimilars increased from 47 in Q1 to 60 by Q3, providing additional choices for more affordable healthcare treatment options. The rise in interchangeable biosimilars, from 8 to 14, emphasizes the value of biologics that can be substituted at the pharmacy, where state laws permit, for the reference product ...
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