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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.
Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (contains list of substances) Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Union and third countries in drug precursors.
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 ]
BRUSSELS (Reuters) -The European Commission published its first list of critical medicines, as part of a wider overhaul of laws governing the 136 billion euro ($148 billion) pharmaceuticals ...
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] Zessly was approved for use in the European Union in May 2018. [22]
See also the list of the top 100 bestselling branded drugs, ranked by sales. Abbreviations are used in the list as follows: INN = International Nonproprietary Name; BAN = British Approved Name; USAN = United States Adopted Name; Two-letter codes for countries
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.
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]
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