Mabpharm files infliximab copy biological application in China

Biosimilars/News | Posted 31/01/2020 post-comment0 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).

24-AA011041

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.

Related articles
Copy biologicals approved in China

Biosimilars of infliximab

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

Source: Mabpharm, Sorrento

comment icon Comments (0)
Post your comment
Related content
FDA approves filgrastim biosimilar Nypozi
Filgrastim Grastofil V13H23
Biosimilars/News Posted 04/09/2024
FDA approves third aflibercept biosimilar Ahzantive
Bevacizumab VEGF Lucentis V21D02MN
Biosimilars/News Posted 13/08/2024
China approves Simcare’s cetuximab beta Enlituo
Cancer Cell V13I20
Biosimilars/News Posted 30/07/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010