Mabpharm files infliximab copy biological application in China Posted 31/01/2020

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].

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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

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