South Korean biotechnology company Celltrion announced on 23 April 2018 that Australia’s regulatory body, the Therapeutic Goods Administration (TGA), has approved its rituximab biosimilar, Truxima (CT‑P10).
Australia approves rituximab biosimilar Truxima
Biosimilars/News | Posted 27/04/2018 0 Post your comment
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.
The product is a proposed biosimilar to Roche’s MabThera/Rituxan (rituximab), which had worldwide sales of CHF 7.3 billion (Euros 6.4 billion) in 2016, before the advent of biosimilars. The patents on MabThera/Rituxan expired in the US in September 2016 and in Europe in February 2013 [1].
Truxima has been approved by the TGA for the treatment of B-cell non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, microscopic polyangiitis, rheumatoid arthritis and Wegener’s granulomatosis.
Celltrion received approval for CT‑P10 from the Korean Ministry of Food and Drug Safety (MFDS) in November 2016 [2] and from the European Commission in February 2017 [3]. The proposed rituximab biosimilar was also accepted for review by the US Food and Drug Administration in June 2017 [4], but was rejected in April 2018 [5].
This approval marks Australia’s second rituximab biosimilar. The TGA approved Riximyo (rituximab) made by Sandoz in November 2017 [6].
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References
1. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar rituximab approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 27]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-South-Korea
3. 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 27]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-first-cancer-biosimilar-Truxima
4. 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 27]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Celltrion-Teva-s-rituximab-biosimilar
5. 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 Apr 27]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Celltrion-Teva-s-rituximab-and-trastuzumab-biosimilars
6. GaBI Online - Generics and Biosimilars Initiative. TGA approves three biosimilars but fewer generics in 2017 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 27]. Available from: www.gabionline.net/Reports/TGA-approves-three-biosimilars-but-fewer-generics-in-2017
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Source: TGA
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