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 Biologics License Application (BLA) submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data generated in two clinical studies; one in rheumatoid arthritis [1] and one in CD20-positive B-cell non-Hodgkin's lymphoma (NHL) patients [2]. The results of these studies, according to Amgen, confirmed no clinically meaningful differences between ABP 798 and the originator biological, Rituxan (rituximab).

The candidate rituximab biosimilar is one of four biosimilars for oncology indications that Amgen is developing in collaboration with Allergan (Actavis) [3]. Two of these, Kanjinti (trastuzumab-anns) and Mvasi (bevacizumab-awwb) have already been approved by FDA [4].

There are already two FDA-approved biosimilars for Rituxan; Teva/Celltrion’s Truxima and Pfizer’s Ruxience [4].

Amgen has a total of 10 biosimilars in its portfolio, four of which have been approved in the US [4] and three that are approved in the European Union (EU) [5].

Related article
Biosimilars of rituximab

References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for rituximab biosimilar ABP 798 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-rituximab-biosimilar-ABP-798
2. GaBI Online - Generics and Biosimilars Initiative. More positive phase III results for rituximab biosimilar ABP 798 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Biosimilars/Research/More-positive-phase-III-results-for-rituximab-biosimilar-ABP-798
3. GaBI Online - Generics and Biosimilars Initiative. Amgen expands biosimilars programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Biosimilars/News/Amgen-expands-biosimilars-programme
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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