Rituximab biosimilar ABP 798 submitted to FDA

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Rituximab biosimilar ABP 798 submitted to FDA

Biosimilares/Novedades | Posted 07/02/2020 0 Post your comment

US-based biotech giant Amgen and its partner Allergan announced on 19 December 2019 that their rituximab biosimilar (ABP 798) had been successfully submitted to the US Food and Drug Administration (FDA) for review.

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].

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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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Source: Amgen