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Australia approves rituximab biosimilar Truxima Posted 27/04/2018

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).

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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