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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list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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 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 ...
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 ...
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 ...
Amgen's drug will be marketed under the name Bkemv. Biosimilars are close copies of complex biological drugs. In 2022, the company said that Bkemv met the main goal of a late stage study, where ...
Instead there are biosimilars. Biosimilars are defined by the FDA as, "a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product." [28] Currently, the only two biologic treatments for IBD that have approved biosimilars are adalimumab and infliximab. [11]