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FDA approves first rituximab biosimilar Truxima Posted 07/12/2018

On 28 November 2018, the US Food and Drug Administration (FDA) approved its first rituximab biosimilar, Truxima (rituximab-abbs), the first biosimilar for the treatment non-Hodgkin’s lymphoma (NHL).

The product is a proposed biosimilar to Roche’s MabThera/Rituxan (rituximab), which had sales of CHF 7.3 billion (Euros 6.4 billion) in 2016, before the advent of biosimilars [1]. Since then sales have been reduced by competition from biosimilars. The patents on MabThera/Rituxan expired in the US in September 2016 and in Europe in February 2013 [2].

Truxima is produced by South Korean biotechnology company Celltrion and Israel-based Teva Pharmaceutical Industries (Teva). The companies received a recommendation for approval from FDA’s Oncologic Drugs Advisory Committee (ODAC) for their rituximab biosimilar, CT‑P10, on 10 October 2018 [3].

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 (CT‑P10) has been approved for the treatment of adult patients in three indications:

  • Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent
  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy
  • Non-progressing (including stable disease), low-grade, CD20­positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy.

FDA’s approval of Truxima is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrates Truxima is biosimilar to Rituxan.

Truxima has been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

The approval of Truxima marks Celltrion/Teva’s first biosimilar to be approved by FDA. Truxima (rituximab) was approved in Europe back in February 2017 [4]. The pair also have three other rituximab biosimilars approved in Europe: Blitzima, Ritemvia and Rituzena (previously Tuxella) [5], and have received European approval for their infliximab biosimilar, Remsima, in September 2013 [6], and for their trastuzumab biosimilar, Herzuma, in February 2018 [7].

Celltrion and Teva entered into an exclusive partnership in October 2016 to commercialize Truxima in the US and Canada. Teva and Celltrion have reached a settlement agreement with Genentech, including entry terms, although they say, ‘the terms and conditions of that agreement are confidential at this time’.

Related article
Biosimilars of rituximab

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-rituximab
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. FDA advisers recommend approval of rituximab biosimilar CT-P10 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisers-recommend-approval-of-rituximab-biosimilar-CT-P10
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 Dec 7]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-first-cancer-biosimilar-Truxima
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for three rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-three-rituximab-biosimilars
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
7. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Herzuma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Herzuma

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Source: Celltrion, Teva, US FDA

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