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
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: Celltrion, US FDA
0
Post your comment