There has been a lot of news recently when it comes to adalimumab biosimilars. Sandoz, Fresenius Kabi, Fujifilm Kyowa Kirin Biologics/Mylan and Viatris have all announced launches of adalimumab biosimilars.
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.
On 15 February 2021, Japan-based Fujifilm Kyowa Kirin Biologics and US-based drugmaker Mylan (now Viatris) announced the launch of its adalimumab biosimilar, Adalimumab Biosimilar 1, in Japan. The biosimilar was approved by Japan’s regulatory agency back in June 2020 [1] and will be the first adalimumab biosimilar to be launched in Japan. Fujifilm Kyowa Kirin Biologics and Mylan (now Viatris) made a collaboration deal in 2018 for an adalimumab biosimilar in Europe [2] and have since commercialized the product in more than 20 countries. They expanded the partnership globally and received US approval in 2020 [3]. However, Hulio is not expected to launch in the US until July 2023 due to a patent license agreement with AbbVie [3].
On 16 February 2021, Sandoz Canada announced the launch of its adalimumab biosimilar, Hyrimoz, in Canada. Hyrimoz was approved by Health Canada on 4 November 2020 to treat nine of the 12 indications of the reference biological Humira. These include the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, psoriasis and adult uveitis. Hyrimoz is the fourth Sandoz biosimilar to be authorized in Canada during the last 11 months [4].
On 18 February 2021, Fresenius Kabi Canada announced the launch of Idacio, its adalimumab biosimilar, in Canada. Idacio is approved for all indications of the reference medicine in the areas of rheumatology, gastroenterology and dermatology. Idacio received approval from Health Canada on 30 October 2020 and is the first biosimilar introduced by Fresenius Kabi in North America.
Viatris (formerly Mylan) also announced an adalimumab launch on 18 February 2021. Viatris Canada announced that Health Canada had approved Hulio, which is licensed from Fujifilm Kyowa Kirin Biologics, and approved in Canada for all adalimumab indications. The approval of Hulio was based on a comprehensive analytical, preclinical and clinical programme. The phase III clinical study, ARABESC, conducted by Fujifilm Kyowa Kirin Biologics, demonstrated no clinically meaningful differences in terms of safety, efficacy and immunogenicity compared with the reference product, Humira, in rheumatoid arthritis patients.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for first adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 5]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-first-adalimumab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Mylan and Fujifilm Kyowa Kirin Biologics partner on adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 5]. Available from: www.gabionline.net/Pharma-News/Mylan-and-Fujifilm-Kyowa-Kirin-Biologics-partner-on-adalimumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves Mylan’s adalimumab biosimilar Hulio [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 5]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-Mylan-s-adalimumab-biosimilar-Hulio
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
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Source: Fresenius Kabi, Fujifilm Kyowa Kirin Biologics, Sandoz, Viatris
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