FDA reviews adalimumab biosimilar SB5 Posted 26/10/2018

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Samsung Bioepis announced on 27 September 2018 that the regulatory submission for its proposed adalimumab biosimilar (SB5) had been accepted by the US Food and Drug Administration (FDA).

The adalimumab product (SB5) from Samsung Bioepis is a proposed biosimilar to AbbVie’s Humira (adalimumab), which had worldwide sales of US$18.4 billion in 2017. The patents on Humira expired in the US in November 2017 and in Europe in June 2017 [1]. 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 until January 2023 [2, 3].

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.

Samsung Bioepis is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen Idec. The company received approval from the European Medicines Agency (EMA) for Imraldi (SB5) in June 2016 [4]. It has also received approval for Hadlima (SB5) from Korea's Ministry of Food and Drug Safety [5], Australia’s Therapeutic Goods Administration [6] and Health Canada [7].

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References
1. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
2. 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 2018 Oct 26] Available from: www.gabionline.net/Biosimilars/News/Amgen-s-adalimumab-biosimilar-will-only-be-launched-in-US-in-2023
3. 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 2018 Oct 26] Available from: www.gabionline.net/Biosimilars/General/AbbVie-and-Samsung-Bioepis-reach-patent-deal-over-Humira-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilar Imraldi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 26]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilar-Imraldi
5. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and trastuzumab biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 26]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-trastuzumab-biosimilars-approved-in-South-Korea
6.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia
7.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada

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Source: Samsung Bioepis

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