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.
Tanvex BioPharma’s filgrastim biosimilar comes under fire
Biosimilars/News | Posted 08/11/2019 0 Post your comment
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.
Related article
Biosimilars of filgrastim
Reference
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
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.
Source: Tanvex
Research
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
Biosimilars in inflammatory bowel disease: are we ready for multiple switches
General
Humira's resilience in the face of biosimilar competition
Boehringer Ingelheim to expand access to adalimumab biosimilar
Comments (0)
Post your comment