Tanvex BioPharma’s filgrastim biosimilar comes under fire Posted 08/11/2019

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) is having a rough time lately. In July 2019, Amgen filed an infringement lawsuit against the company regarding its filgrastim biosimilar, TX01. Then in September 2019, US Food and Drug Administration (FDA) rejected Tanvex’s application for approval of TX01.

The company announced on 25 July 2019 that Amgen had sued the company regarding the FDA application for its filgrastim biosimilar, TX01, which was submitted to FDA in October 2018 [1].

On 23 July 2019, the infringement lawsuit against Tanvex and two of its affiliates (Tanvex Biologics Corporation and Tanvex BioPharma USA) was submitted by Amgen in the Southern District of California and alleges infringement of US Patent No.9,856,287 (the ‘287 patent) under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Tanvex filed a response to Amgen’s complaint on 24 September 2019 that included defences and counterclaims of non-infringement and invalidity.

Tanvex submitted its first biosimilar application to FDA for its proposed filgrastim biosimilar TX01 in October 2018 [1]. However, on 25 September 2019, the company announced that it had received a complete response letter (CRL) from FDA regarding its application.

Tanvex says that the CRL indicates that the review cycle for the biosimilar application is complete, however, ‘there are certain items that need to be addressed before the application can be approved’. The company added that ‘FDA did not request additional clinical data or express concern related to product safety’.

Tanvex says that it ‘plans to work closely with the FDA to address all items in the CRL’ and is planning to resubmit the biosimilar application ‘as soon as possible’. The FDA’s target review cycle for resubmissions is six months.

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1. GaBI Online - Generics and Biosimilars Initiative. Tanvex BioPharma submits filgrastim biosimilar to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: www.gabionline.net/Biosimilars/News/Tanvex-BioPharma-submits-filgrastim-biosimilar-to-FDA

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Source: Tanvex

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