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Japanese approval for first adalimumab biosimilar Posted 03/07/2020

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Japan-based Fujifilm Kyowa Kirin Biologics announced on 29 June 2020 that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its adalimumab biosimilar FKB327 in Japan.

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 product, which will be called ‘Adalimumab Biosimilar 1’, is the first adalimumab biosimilar to be approved in Japan.

Fujifilm Kyowa Kirin Biologics is a joint venture set up by Fujifilm and biotech firm Kyowa Hakko Kirin back in 2011 [1]. The company is the marketing authorization holder in Japan, but US-based drugmaker Mylan will be in charge of commercialization. The two made a deal back in April 2018 allowing Mylan to commercialize its adalimumab biosimilar FKB327. Mylan also has exclusive rights to commercialize FKB327 in Europe [2].

Fujifilm Kyowa Kirin Biologics and Mylan gained European approval for Hulio (FKB327) in September 2018 [6] and Mylan launched the product in Europe in October 2018 [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Fujifilm and Kyowa Hakko Kirin in biosimilars joint venture [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from: www.gabionline.net/Biosimilars/News/Fujifilm-and-Kyowa-Hakko-Kirin-in-biosimilars-joint-venture
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 2020 Jul 3]. Available from: www.gabionline.net/Pharma-News/Mylan-and-Fujifilm-Kyowa-Kirin-Biologics-partner-on-adalimumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Mylan launches adalimumab biosimilar Hulio in Spain [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from: www.gabionline.net/Biosimilars/News/Mylan-launches-adalimumab-biosimilar-Hulio-in-Spain

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Source: Fujifilm Kyowa Kirin Biologics

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