EMA accepts application for adalimumab biosimilar from Fujifilm Kyowa Kirin Biologics

Biosimilares/Novedades | Posted 02/06/2017 post-comment1 Post your comment

Japan-based biosimilars developer Fujifilm Kyowa Kirin Biologics announced on 22 May 2017 that its application for approval for its proposed adalimumab biosimilar (FKB327) had been accepted by the European Medicines Agency (EMA).


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 is a proposed biosimilar to AbbVie’s Humira (adalimumab), which had worldwide sales of US$14 billion in 2015, making it a lucrative target for biosimilars manufacturers. The patents on Humira will expire in the US in November 2017 and in Europe in June 2017 [1].

The submission includes data from a phase III global clinical study of FKB327 at sites in the US, Europe and other countries, which compared the efficacy and safety of FKB327 with Humira in patients with moderate to severe rheumatoid arthritis. In this study, FKB327 met the primary endpoint and pre-specified criteria for equivalence, and there were no significant differences in the rate of adverse events between FKB327 and Humira.

Fujifilm Kyowa Kirin Biologics is a joint venture between Japanese digital camera maker Fujifilm Corporation and biotech firm Kyowa Hakko Kirin. Adalimumab was the company’s initial focus, but it has also stated that it ‘plans to start clinical trials of one biosimilar every year after 2014 and intends to hold talks with other companies for biosimilar collaborations’ [2]. In July 2015, it entered into an agreement with pharma giant AstraZeneca for the development and commercialization of its candidate bevacizumab biosimilar, FKB238 [3].

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1. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
2. GaBI Online - Generics and Biosimilars Initiative. Fujifilm and Kyowa launch biosimilars joint venture [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 2]. Available from: www.gabionline.net/Biosimilars/News/Fujifilm-and-Kyowa-launch-biosimilars-joint-venture
3. GaBI Online - Generics and Biosimilars Initiative. AstraZeneca and Fujifilm Kyowa Kirin Biologics to collaborate on bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 2]. Available from: www.gabionline.net/Pharma-News/AstraZeneca-and-Fujifilm-Kyowa-Kirin-Biologics-to-collaborate-on-bevacizumab-biosimilar

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Source: Fujifilm Kyowa Kirin Biologics

comment icon Comments (1)
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Posted 05/06/2017 by VIVAN Life Sciences

I like this. Great one. Thanks for the best info. Good job.

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