Biosimilar rituximab approved in South Korea Posted 02/12/2016

South Korean biotechnology company Celltrion announced on 17 November 2016 that the company had received approval for its rituximab biosimilar Truxima (CT-P10) from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

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.

Truxima has been approved in South Korea for the treatment of Non-Hodgkin’s Lymphoma, chronic lymphocytic leukaemia and rheumatoid arthritis.

The announcement marks Celltrion’s third biosimilar to gain sales approval in South Korea. The company gained approval for its infliximab biosimilar Remsima in July 2012 and for its trastuzumab biosimilar Herzuma (CT-P6) in January 2014 [1].

Celltrion said that it expects Korea’s regulatory approval of Truxima ‘to pave the way’ for the biosimilar’s approval by the European Medicines Agency (EMA). The company submitted a marketing application for its rituximab biosimilar CT-P10 to EMA in November 2015 [2]. It expects to begin selling the drug in Europe after its approval in 2017 and also said that it plans to file Truxima for review by the US Food and Drug Agency (FDA) by early 2017. Rival biosimilars maker Sandoz submitted an application for approval of its rituximab biosimilar to EMA in May 2016 [4].

The originator product, Roche’s MabThera/Rituxan (rituximab), had sales of CHF 7.05 billion (Euros 6.38 billion) in 2015. The patents on MabThera/Rituxan expired in the US in September 2016 and in Europe in February 2013 [3].

Celltrion’s infliximab biosimilar (Remsima) was approved by EMA in September 2013 [5] and the company submitted a trastuzumab biosimilar application to EMA in October 2016 [6]. The company also received approval for its infliximab biosimilar (CT-P13) in the US in April 2016, claiming it to be the first monoclonal antibody biosimilar approved in the US [7].

Furthermore, Celltrion announced on 14 November 2016 that it had presented data supporting the efficacy and safety of its CT-P10 biosimilar in rheumatoid arthritis patients at the 2016 American College of Rheumatology (ACR) Annual Meeting.

The phase III, randomized, controlled study included 372 rheumatoid arthritis patients (161 patients on CT-P10 and 211 patients on originator rituximab). According to Celltrion, the results ‘showed that overall efficacy, pharmacodynamics and safety profiles were highly similar between CT-P10 and the originator rituximabs (US sourced originator rituximab and EU sourced originator rituximab)’. Additional data presented at the congress ‘found equivalent pharmacokinetics and similar safety profiles among CT-P10 and the two originator rituximabs sourced from different manufacturers’, according to Celltrion.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion submits rituximab biosimilar application to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-submits-rituximab-biosimilar-application-to-EMA
3. Derbyshire M. Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
4. GaBI Online - Generics and Biosimilars Initiative. Rituximab biosimilar from Sandoz accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-biosimilar-from-Sandoz-accepted-for-review-by-EMA
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
6. GaBI Online - Generics and Biosimilars Initiative. Celltrion submits trastuzumab biosimilar application to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-submits-trastuzumab-biosimilar-application-to-EMA
7. GaBI Online - Generics and Biosimilars Initiative. FDA approves infliximab biosimilar Inflectra [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-infliximab-biosimilar-Inflectra

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Source: Business Wire, The Korea Herald

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