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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list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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 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.
[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] In July 2020, adalimumab-fkjp (Hulio) was approved for use in the United States. [9] [103] [122]
The FDA approved two interchangeable biosimilars to treat macular degeneration. The biosimilars work the same way as Eylea which prevents abnormal blood vessel growth in the eye and helps preserve ...
Out of the 13 approved interchangeable biosimilars in the past, nine were approved without additional switching study data, the FDA said. KEY QUOTES "Both biosimilars and interchangeable ...
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 ...
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 ...
The FDA approved Samsung Bioepis Co., Ltd.'s Renflexis (infliximab-abda) in April 2017. [1] Biogen released another biosimilar, Flixabi, which was approved in Germany, the UK, and the Netherlands. [62] Flixabi was approved for use in the European Union in May 2016. [5] In December 2017, Ixifi (infliximab-qbtx) was approved in the United States. [4]
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