Celltrion resubmits biosimilar rituximab to FDA

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Celltrion resubmits biosimilar rituximab to FDA

Biosimilars/News | Posted 01/06/2018 0 Post your comment

South Korean biotechnology company Celltrion announced on 30 May 2018 that it had resubmitted its application for marketing approval for its candidate rituximab biosimilar, CT‑P10, to the US Food and Drug Administration (FDA).

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

Celltrion’s rituximab biosimilar candidate, CT‑P10, is a candidate biosimilar for Roche’s MabThera/Rituxan (rituximab), which had sales of CHF 7.3 billion (Euros 6.4 billion) in 2016, before the advent of biosimilars. Celltrion and Israeli generics giant Teva Pharmaceutical Industries (Teva) made a collaboration agreement for Celltrion’s candidate rituximab biosimilar, Truxima (CT‑P10), and its candidate trastuzumab biosimilar, Herzuma (CT‑P6) in October 2016 [1]. The companies filed applications for approval of the biosimilars with FDA in June and July 2017, respectively [2, 3].

The FDA submission for CT‑P10 [along with its trastuzumab biosimilar (CT‑P6)] 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].

The resubmission follows ‘progress’ made by Celltrion ‘addressing the concerns raised by FDA in the Warning Letter’. The company adds that it ‘is committed to working with the agency to fully resolve all outstanding issues with the highest priority and urgency’. Celltrion also states that FDA ‘has confirmed the resumption of the review procedure for the two proposed biosimilars upon the resubmission of BLAs’.

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

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Source: Celltrion