US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 20 July 2021 that its partner, China-based Mabpharm, had received marketing approval from China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), for its infliximab ‘biobetter’ (CMAB008).
Infliximab is a chimeric monoclonal antibody against tumour necrosis factor-alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.
Sorrento is calling this product a ‘biobetter’, i.e. an improvement to the originator product, Johnson & Johnson and Merck’s Remicade (infliximab), rather than a ‘copy biological’, which is a structural imitation of the originator. The reason for this, according to Sorrento, is that CMAB008 was developed using Chinese hamster ovary (CHO) cells rather than the murine (mouse) cells used for the originator infliximab. This they say has resulted ‘in a better safety profile and lower immunogenicity when compared to the currently marketed TNF-α antibody’ … ‘while demonstrating the same efficacy as the parent mouse antibody’.
Mabpharm filed the application for approval of CMAB008 with the NMPA back in January 2020 . The approval by the NMPA covers six different indications, including adult ulcerative colitis, ankylosing spondylitis, rheumatoid arthritis, adult and childhood Crohn’s disease, fistula Crohn’s disease and psoriasis.
Sorrento, through a global licensing agreement with Mabpharm, owns the global rights to the Mabpharm infliximab product (CMAB008) outside of China. The company says that it plans to file a Biologics License Application (BLA) for CMAB008 in the US and Europe in 2021 and is planning to meet with the relevant authorities to discuss the path forward.
Sorrento also made a deal back in August 2015 with MabTech, a holding company for China mAb Biotechs, for four monoclonal antibodies, including a cetuximab (STI 001) and a rituximab copy biological (STI 002) . Mabpharm is also developing nivolumab (CMAB819) and pertuzumab (CMAB810) copy biologicals [3, 4].
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘copy biologicals’ or ‘biobetter’ approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
Copy biologicals approved in China
Biosimilars of infliximab
Biobetters rather than biosimilars
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1. GaBI Online - Generics and Biosimilars Initiative. Mabpharm files infliximab copy biological application in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 10]. Available from: www.gabionline.net/biosimilars/news/Mabpharm-files-infliximab-copy-biological-application-in-China
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for cetuximab and infliximab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 10]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-cetuximab-and-infliximab-copy-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of nivolumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 10].
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pertuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 10]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pertuzumab
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