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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.
Yesafili is already approved as a biosimilar in Europe and the United Kingdom, and is approved in Canada and is expected to launch there by July 2025, Biocon Biologics said in a press release.
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. Before this, the company existed as an independent pharmaceutical manufacturer until ...
Infliximab was approved for medical use in the United States in 1998, [23] and in the European Union in August 1999. [19] Infliximab biosimilars have been approved in the EU (2013), in Japan (2014), and in the United States (2016, 2017, 2019). [1] [4] [2] It is on the World Health Organization's List of Essential Medicines. [25]
The applicant for this medicinal product is QILU PHARMA SPAIN S.L. [39] Rimmyrah is a biosimilar medicinal product that is highly similar to the reference product Lucentis (ranibizumab), which was authorized in the EU in January 2007. [39] Rimmyrah was approved for medical use in the European Union in January 2024. [6] [40]
Alvotech settles with J&J to launch Stelara biosimilar in Europe, Canada. February 15, 2024 at 7:00 AM ... 2025, if it gets U.S. FDA approval. The regulator's decision is expected by April 16. ...
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 ...
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 ...