FDA accepts application for Celltrion/Teva’s rituximab biosimilar

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FDA accepts application for Celltrion/Teva’s rituximab biosimilar

Biosimilars/News | Posted 11/08/2017 0 Post your comment

South Korean biotechnology company Celltrion and partner Israeli generics giant Teva Pharmaceuticals (Teva) announced on 29 June 2017 that the regulatory submission for their proposed rituximab biosimilar (CT‑P10) had been accepted by the US Food and Drug Administration (FDA).

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.

Celltrion/Teva’s rituximab biosimilar candidate, CT‑P10, is a candidate biosimilar for Roche’s MabThera/Rituxan (rituximab). CT‑P10. The biosimilar application for CT‑P10 includes data comparing CT‑P10 and reference rituximab in terms of efficacy, safety, immunogenicity, pharmacodynamics (PD) and pharmacokinetics (PK). These trials were conducted in over 600 patients and include up to 104 weeks of data.

The originator product, Roche’s MabThera/Rituxan (rituximab), had 2015 sales of CHF 7.05 billion (Euros 6.38 billion). The patents on MabThera/Rituxan expired in the US in September 2016 and in Europe in February 2013 [1].

CT‑P10 (Truxima) was approved by the European Commission in February 2017 [2] and has been launched in the UK, Germany, The Netherlands, Spain and South Korea. It has also been approved by the European Medicines Agency in May 2017 as Blitzima, Ritemvia and Tuxella [3].

Celltrion and Teva entered into an exclusive partnership for two of Celltrion’s monoclonal antibody biosimilars in the US and Canada in October 2016. The agreement involves Celltrion’s rituximab biosimilar (CT-P10) and trastuzumab biosimilar (CT-P6) [4].

References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 11]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for first cancer biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 11]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-first-cancer-biosimilar-Truxima
3. GaBI Online - Generics and Biosimilars Initiative. EMA approval for insulin and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 11]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-insulin-and-rituximab-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Teva and Celltrion to partner on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 11]. Available from: www.gabionline.net/Biosimilars/News/Teva-and-Celltrion-to-partner-on-biosimilars

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Source: Celltrion, Teva