Tanvex BioPharma submits filgrastim biosimilar to Health Canada

Biosimilars/News | Posted 01/02/2019 post-comment0 Post your comment

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 16 January 2019 that it had submitted a biosimilar application to Health Canada 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]. In Canada, according to IMS data, filgrastim product sales (including Neupogen and Grastofil) were over US$100 million for the 12 months ending 30 November 2018.

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.

This is Tanvex’s second submission for its filgrastim biosimilar candidate. The company also had its application for TX01 accepted by the US Food and Drug Administration (FDA) back in November 2018 [2].

According to Dr Allen Chao, CEO of Tanvex BioPharma, this additional filing confirms the support of the company for the biosimilar market and its strategy ‘to explore additional opportunities that improve affordability and access to high quality biologics’.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Tanvex BioPharma submits filgrastim biosimilar to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. Available from: www.gabionline.net/Biosimilars/News/Tanvex-BioPharma-submits-filgrastim-biosimilar-to-FDA

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Source: Tanvex

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