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Tanvex BioPharma submits filgrastim biosimilar to FDA Posted 23/11/2018

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 1 October 2018 that it had submitted its first biosimilar application to the US Food and Drug Administration (FDA). The application is for its proposed filgrastim biosimilar TX01.

TX01 is a proposed biosimilar to Amgen’s Neupogen (filgrastim), which had worldwide sales of US$1.4 billion in 2013 before the approval of the first filgrastim biosimilars. The patents on Neupogen expired in the US in December 2013 and in Europe in 2006 [1].

Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy for cancer treatment.

The application is based on the results of pivotal clinical studies for TX01, which the company initiated back in October 2016. Tanvex announced that it would be seeking the same indications for TX01 as the Neupogen, which is currently approved for the treatment of chemotherapy-induced neutropenia.

There are already three filgrastim biosimilars approved in the US. Sandoz’s Zarxio (filgrastim-sndz), Biocon/Mylan’s Fulphila (pegfilgrastim-jmdb) and Pfizer’s (Hospira’s) Nivestym (filgrastim-aafi) were approved in March 2015, June 2018 and July 2018, respectively [1]. Two other proposed filgrastim biosimilars from Adello and Apotex are also still in the approval process, although an FDA decision on both is well overdue – the applications were filed in September 2017 and February 2015, respectively [2, 3].

Tanvex is also working on biosimilars of trastuzumab (TX05) and bevacizumab (TX16). In December 2017 Tanvex reported positive results from its phase I pharmacokinetics trial with TX16 in colorectal cancer, which it is carrying out in the US. The company also has an ongoing phase III trial and extension for TX05, which it is carrying out in Hungary.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 23]. Available from: http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for Adello’s filgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 23]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Adello-s-filgrastim-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Second Apotex biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 23]. Available from: www.gabionline.net/Biosimilars/News/Second-Apotex-biosimilar-under-FDA-review

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Source: Tanvex

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