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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This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
Bekemv is a biosimilar medicinal product. [50] It is highly similar to the reference product Soliris (eculizumab), which was authorized in the EU on 20 June 2007. [50] Data show that Bekemv has comparable quality, safety and efficacy to Soliris. [50] Bekemv was approved for medical use in the European Union in April 2023. [51] [1]
The company produces and sells a variety of medicines, with 1,400 approved therapeutic molecules in its portfolio. [30] It owns brands (like Viagra , Xanax , Lipitor ), [ 6 ] [ 31 ] generics , including branded and complex generics, biosimilars , [ 32 ] [ 33 ] and over-the-counter (OTC) drugs and active pharmaceutical ingredients .
In 2018, the biosimilars Halimatoz, [18] Hefiya, [19] Hyrimoz, [22] and Hulio [21] were approved for use in the European Union. Adalimumab biosimilars became available in the European Union in 2018, [112] allowing the National Health Service to make record-breaking cost-savings, [113] as this is the single most expensive drug used in NHS ...
The approval, applicable in all 27 countries of the European Union, is based on studies from two late-stage trials that showed the drug was effective and safe in eligible patients.
In 2015, Sandoz's filgrastim-sndz (Zarxio), obtained the approval of the US Food and Drug Administration (FDA) as a biosimilar. [ 11 ] [ 27 ] [ 28 ] This was the first product to be passed under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), as part of the Affordable Care Act . [ 11 ]
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 ...
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