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Clinical trials supporting the approval of adalimumab biosimilars Posted 03/04/2020

Authors from Argentina and the UK critically review the evidence from trials of biosimilars in rheumatoid arthritis (RA) [1].

Adalimumab is one of the top-selling drugs worldwide. The originator product, AbbVie’s Humira had worldwide sales of US$18.4 billion in 2017 and accounted for approximately 65% of AbbVie’s total net revenues in that year.

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The patents on Humira, expired in Europe in June 2017 [2]. However, in the US AbbVie has stated that although the composition of matter patent covering Humira expired in December 2016, non-composition of matter patents covering Humira expire no earlier than 2022. The company has therefore made settlement agreements with Amgen and Samsung Bioepis delaying the launch of biosimilars in the US until January 2023 [3, 4].

As of 30 March 2020, 10 adalimumab biosimilars are approved in Europe [5]. While five have been approved in the US [6].

The authors investigate the clinical trials carried out to support the approval of three of these biosimilars: Amgen’s ABP 501 (Amjevita/Solymbic), Boehringer Ingelheim’s BI 695501 (Cyltezo) and SB5 from Samsung Bioepis (Imraldi). These are discussed in more detail in the series of articles that follow.

Related articles
Clinical trials for adalimumab biosimilar SB5

Clinical trials for adalimumab biosimilar BI 695501

Clinical trials for adalimumab biosimilar ABP 501

Biosimilars of adalimumab

References
1. Zhao S, Chadwick L, Mysler E, et al. Review of biosimilar trials and data on adalimumab in rheumatoid arthritis. Curr Rheumatol Rep. 2018;20(10):57.
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. Amgen’s adalimumab biosimilar will only be launched in US in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3] Available from: www.gabionline.net/Biosimilars/News/Amgen-s-adalimumab-biosimilar-will-only-be-launched-in-US-in-2023
4. GaBI Online - Generics and Biosimilars Initiative. AbbVie and Samsung Bioepis reach patent deal over Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3] Available from: www.gabionline.net/Biosimilars/General/AbbVie-and-Samsung-Bioepis-reach-patent-deal-over-Humira-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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