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FDA advisers recommend approval of rituximab biosimilar CT-P10 Posted 19/10/2018

US Food and Drug Administration (FDA) advisers have voted unanimously to recommended approval for CT‑P10, a biosimilar version of Roche’s MabThera/Rituxan (rituximab). If approved by FDA, this would be the first rituximab biosimilar approved in the US.

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.

At their meeting on 10 October 2018, advisers from FDA’s ODAC (Oncologic Drugs Advisory Committee) voted unanimously 16−0 to recommend approval of CT‑P10, which is made by South Korean biotechnology company Celltrion and Israel-based Teva Pharmaceutical Industries (Teva), in three Non-Hodgkin’s Lymphoma (NHL) indications of the originator product (Rituxan).

The proposed indications are:
(1) relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) as a single agent
(2) 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
(3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.

The indications for CT‑P10 therefore exclude the NHL indication for ‘previously untreated diffuse large B cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other anthracycline-based chemotherapy regimens’. In addition, the recommendation also excludes four other indications for which the originator product is approved: chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and pemphigus vulgaris (PV).

The ODAC based its recommendation on a review of a comprehensive data package that included foundational analytical biosimilarity data, non-clinical data, clinical pharmacology, immunogenicity and clinical efficacy and safety data. The results of the clinical development programme for CT‑P10, according to Celltrion/Teva, ‘demonstrated that there were no clinically meaningful differences between CT‑P10 and Rituxan in terms of the safety, purity and potency of the product for the three proposed indications’.

Celltrion/Teva’s application for marketing approval of CT‑P10 was initially rejected by FDA [1] but was resubmitted in May 2018 [2]. Celltrion and Teva entered into an exclusive partnership in October 2016 to commercialize both the rituximab biosimilar CT‑P10 and the trastuzumab biosimilar CT‑P6 in the US and Canada [3].

Celltrion received European approval for Truxima (CT‑P10) in February 2017 [4] and subsequently received approval for Blitzima, Ritemvia and Rituzena (previously Tuxella) (CT‑P10) in July 2017 [5].

References
1. 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 Oct 20]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Celltrion-Teva-s-rituximab-and-trastuzumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion resubmits biosimilar rituximab to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 20]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-resubmits-biosimilar-rituximab-to-FDA
3. GaBI Online - Generics and Biosimilars Initiative. Teva and Celltrion to partner on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 20]. Available from: www.gabionline.net/Biosimilars/News/Teva-and-Celltrion-to-partner-on-biosimilars
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 Oct 20]. 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 Oct 20]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-three-rituximab-biosimilars

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Source: US FDA

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