FDA rejects botulinum toxin biosimilar from Evolus Posted 06/07/2018

US-based Evolus announced on 16 May 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of DWP‑450 (prabotulinumtoxinA).

Evolus received a complete response letter (CRL) regarding the company’s Biologics License Application (BLA) for its botulinum toxin biosimilar. The deficiencies cited by FDA in the CRL were ‘isolated to items related to chemistry, manufacturing and controls (CMC) processes’, according to Evolus. The company also points out that ‘no deficiencies were related to clinical or non-clinical matters’. Despite the setback, Evolus says that it ‘expects to respond with a complete submission to FDA within 90 days’.

DWP‑450 is a candidate biosimilar for Allergan’s cosmetic blockbuster Botox (onabotulinumtoxinA). Botox is indicated for the treatment of moderate to severe glabellar lines, lateral canthal lines and forehead lines.

This is not the only rejection of a biosimilar application by FDA during 2018. This latest rejection follows the agency’s rejection of Celltrion/Teva’s biosimilar rituximab and trastuzumab applications earlier in April 2018 [1]. US pharma giant Pfizer also had its application for its trastuzumab biosimilar (PF 05280014) rejected by FDA in April 2018 [2]. Then Sandoz, part of Novartis, announced on 2 May 2018 that its application for biosimilar rituximab, Rixathon/Riximyo (GP2013), had also been rejected [2].

Related articles
FDA rejects Pfizer’s epoetin alfa biosimilar

FDA rejects pegfilgratim biosimilar from Coherus

References
1.  GaBI Online - Generics and Biosimilars Initiative. FDA rejects Celltrion/Teva’s rituximab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Celltrion-Teva-s-rituximab-and-trastuzumab-biosimilars
2.  GaBI Online - Generics and Biosimilars Initiative. FDA rejects trastuzumab and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-trastuzumab-and-rituximab-biosimilars

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 © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: Evolus

Comments (0)