Celltrion resubmits biosimilar trastuzumab to FDA

Biosimilars/News | Posted 22/06/2018 post-comment0 Post your comment

South Korean biotechnology company Celltrion announced on 18 June 2018 that it had resubmitted its application for marketing approval for its candidate trastuzumab biosimilar, CT‑P6, to the US Food and Drug Administration (FDA).

Trastuzumab Herceptin V13D12

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Celltrion’s trastuzumab biosimilar candidate, CT‑P6, is a candidate biosimilar for Roche’s Herceptin (trastuzumab), which had sales of CHF 7.0 billion (US$7.5 billion) in 2017. Celltrion and Israeli generics giant Teva Pharmaceutical Industries (Teva) made a collaboration agreement for Celltrion’s candidate trastuzumab biosimilar, Herzuma (CT‑P6) and its candidate rituximab biosimilar, Truxima (CT‑P10) in October 2016 [1]. The companies announced that they had filed applications for approval of the trastuzumab and rituximab biosimilars with FDA in July and June 2017, respectively [2, 3].

The FDA submission for CT‑P6 [along with its rituximab biosimilar (CT‑P10)] was rejected in April 2018 after the FDA Committee issued a complete response letter (CRL) related to the warning letter issued by the agency in January 2018. The warning letter highlighting issues including poor aseptic techniques during filling of batches and lack of follow-up regarding discrepancies or failure of batches following an inspection of Celltrion’s manufacturing site in South Korea [4].

Celltrion confirmed that the resubmission was completed in May 2018. It also states that FDA has notified the company of its reinspection schedule regarding regular audit results and ‘has confirmed the resumption of the review procedure for the two proposed biosimilars upon the resubmission of the aBLAs’.

Celltrion added that, according to FDA regulations, ‘the approval procedure will be usually finalized within six months from the resubmission’. The company therefore expects the two biosimilars to be approved by FDA by the end of 2018.

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Biosimilars of trastuzumab

1.  GaBI Online - Generics and Biosimilars Initiative. Teva and Celltrion to partner on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 22]. Available from: www.gabionline.net/Biosimilars/News/Teva-and-Celltrion-to-partner-on-biosimilars
2.  GaBI Online - Generics and Biosimilars Initiative. Two trastuzumab biosimilars submitted to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 22]. Available from: www.gabionline.net/Biosimilars/News/Two-trastuzumab-biosimilars-submitted-to-FDA
3.  GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for Celltrion/Teva’s rituximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Celltrion-Teva-s-rituximab-biosimilar
4.  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 Jun 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Celltrion-Teva-s-rituximab-and-trastuzumab-biosimilars

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Source: Celltrion

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