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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.
Sandoz Group AG is a Swiss company that focuses on generic pharmaceuticals and biosimilars. [4] Prior to October 2023, it was part of a division of Novartis that was established in 2003, when Novartis united all of its generics businesses under the name Sandoz.
At the end of 2021, Alvotech had seven biosimilars in development, the most advanced of which was a biosimilar for Humira, which has been approved for use in the EU. [32] In December 2021, the company announced that it was entering a merger with Special-purpose acquisition company (or SPAC) Oaktree Acquisition Corp. II with the aim of listing ...
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 ...
This listing is limited to those independent companies and subsidiaries notable enough to have their own articles in Wikipedia. Both going concerns and defunct firms are included, as well as firms that were part of the pharmaceutical industry at some time in their existence, provided they were engaged in the production of human (as opposed to veterinary) therapeutics.
The Swiss company has said that its adjusted core profit margin would likely be 18-19% this year, down from 21.3% in 2022, weighed down by higher marketing expenses and cost inflation, but the ...
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 February 2017, Lifmior was approved for use in the European Union. [59] It was withdrawn from the market in February 2020. [60] In June 2017, Erelzi was approved for use in the European Union. [3] In March 2019, YLB113 (Etanercept biosimilar by YL Biologics) was approved in Japan. [61] In April 2019, Eticovo received FDA approval. [62] [63]
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