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FDA rejects Celltrion/Teva’s rituximab and trastuzumab biosimilars Posted 20/04/2018

South Korean biotechnology company Celltrion announced on 6 April 2018 that it had received complete response letters (CRLs) from the US Food and Drug Administration (FDA) regarding its candidate rituximab (CT‑P10) and trastuzumab (CT‑P6) biosimilars.

Teva and Celltrion entered into a collaboration involving Celltrion’s candidate rituximab (CT-P10) and trastuzumab (CT-P6) biosimilars in October 2016 [1].

The companies filed applications for approval of the biosimilars with FDA in June and July 2017, respectively [2, 3]. CT‑P10 is a proposed biosimilar of Roche’s autoimmune diseases and blood cancer treatment Rituxan (rituximab). CT‑P6 is a proposed biosimilar of Roche’s gastric and breast cancer treatment Herceptin (trastuzumab), which had 2017 worldwide sales of CHF 7.0 billion (US$7.5 billion).

However, following an inspection of Celltrion’s manufacturing site in South Korea, FDA issued a warning letter highlighting issues including poor aseptic techniques during filling of batches and lack of follow-up regarding discrepancies or failure of batches.

As a result of the problems highlighted in the warning letter, FDA then issued two CRLs rejecting the biosimilars.

Despite the setback, Celltrion remains positive and in a statement said that it ‘is making progress addressing the concerns raised by the FDA in a Warning Letter issued in January and is committed to working with the agency to fully resolve all outstanding issues with the highest priority and urgency’.

The company goes on to say that it ‘is confident that the issues raised by the FDA will be resolved in a timely manner’. It expects to resubmit the biosimilar applications ‘relatively soon’ and still expects to get the two drugs approved before the end of 2018.

In Europe, Celltrion’s rituximab biosimilar, Truxima, was approved in February 2017 [4] and its trastuzumab biosimilar, Herzuma, was approved in February 2018 [5].

Related articles
Biosimilars of rituximab

Biosimilars of trastuzumab

Biosimilar trastuzumab approved in Korea

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 Apr 20]. 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 Apr 20]. 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 Apr 20]. Available from: www.gabionline.net/Biosimilars/News/Two-trastuzumab-biosimilars-submitted-to-FDA
4. GaBI Online - Generics and Biosimilars Initiative. EC approval for first cancer biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 20]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-first-cancer-biosimilar-Truxima
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Herzuma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 20]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Herzuma

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Source: Celltrion, US FDA

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