Mabpharm files infliximab copy biological application in China

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Mabpharm files infliximab copy biological application in China

Biosimilars/News | Posted 31/01/2020 0 Post your comment

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 6 January 2020 that its partner, China-based Mabpharm, had filed a marketing application with China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) for its infliximab copy biological (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.

The originator product, Johnson & Johnson and Merck’s Remicade (infliximab) had worldwide sales of US$9.3 billion in 2014, before the advent of alternative infliximab products. The patents on Remicade expired in the US in September 2018 and in Europe in February 2015 [1].

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 in 2020.

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) [2].

Editor’s comment
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 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.

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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
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 2020 Jan 31]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-cetuximab-and-infliximab-copy-biologicals

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Source: Mabpharm, Sorrento