FDA and EMA file acceptance of Biogen’s tocilizumab biosimilar

Biogen announced on 9 December 2022 that the US Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (BLA) for BIIB800, a biosimilar candidate referencing Roche’s Actemra/RoActemra (tocilizumab); and on 30 September 2022 that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for BIIB800.

Tocilizumab is a humanized monoclonal antibody which acts against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of arthritis in children [1].

The originator product, Actemra/RoActemra (tocilizumab), was approved by EMA in 2009 and by FDA in 2010. The patents on Actemra/RoActemra expired in the US in 2015 and Europe in 2017 [2] and several biosimilar versions of this product have already been approved in these regions.

In addition, the originator, Actemra/RoActemra (tocilizumab), is now also used to treat chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults or paediatric patients (aged 2 years or older), and severe coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

The BIIB800 tocilizumab biosimilar product has been developed as part of the partnership between Biogen and Bio-Thera Solutions, who entered into a commercialization and license agreement in April 2021 to develop, manufacture and commercialize BIIB800 (also known as BAT1806). Biogen has exclusive regulatory, manufacturing and commercial rights to BIIB800 in all countries excluding China (including Hong Kong, Macau and Taiwan) [3]. The two companies previously reported positive results for their phase III, multicentre, multinational, randomized, double-blind, parallel-group, active-control study (NCT03830203) of BIIB800 which involved 621 patients [3]. In addition, the companies have successfully co-developed other biosimilar products including adalimumab and bevacizumab biosimilar candidates [4-7].

Adalimumab copy biologicals accepted for review in China

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 12]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-tocilizumab
2. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. dot: 10.5639/gabij.2019.0801.003
3. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for tocilizumab biosimilar BAT1806 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 12]. Available from: www.gabionline.net/biosimilars/research/positive-phase-iii-results-for-tocilizumab-biosimilar-bat1806
4. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera launches first adalimumab copy biological in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 12]. Available from: www.gabionline.net/Biosimilars/News/Bio-Thera-launches-first-adalimumab-copy-biological-in-China
5. GaBI Online - Generics and Biosimilars Initiative. Positive results for Bio-Thera’s bevacizumab copy-biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 12]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Bio-Thera-s-bevacizumab-copy-biological
6. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 12]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-bevacizumab-biosimilar-BAT1706
7. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 12]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-bevacizumab-biosimilar-BAT1706

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