FDA rejects botulinum toxin biosimilar from Evolus

Biosimilares/Novedades | Posted 06/07/2018 post-comment0 Post your comment

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).

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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].

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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

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Source: Evolus

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