Fujifilm Kyowa Kirin Biologics announced on 11 April 2018 that it will partner with Mylan to commercialize its adalimumab biosimilar FKB327. Mylan will be granted exclusive commercialization rights for FKB327 in Europe.
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 originator product, AbbVie’s Humira (adalimumab) had worldwide sales of US$18.4 billion in 2017 and accounted for approximately 65% of AbbVie’s total net revenues in 2017 [1]. Sales of the drug in Europe are estimated to be around US$4.1 billion. The patents on Humira will expire in the US in November 2017 and in Europe in June 2017 [2].
Under the terms of the agreement, Fujifilm Kyowa Kirin Biologics grants Mylan an exclusive licence to commercialize FKB327 in Europe and will receive an up-front fee. In addition, Fujifilm Kyowa Kirin Biologics is eligible to receive a subsequent commercialization milestone payment and sales royalties. Mylan will be responsible for the sales activity of the product in European countries and may negotiate commercialization in other territories.
The European Medicines Agency (EMA) accepted the application for the adalimumab biosimilar FKB327 on 18 May 2017 [3]. The companies expect to receive a decision from EMA in the second half of 2018.
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’ [4]. In July 2015, it entered into an agreement with pharma giant AstraZeneca for the development and commercialization of its candidate bevacizumab biosimilar, FKB238 [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for adalimumab biosimilar from Fujifilm Kyowa Kirin Biologics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 4]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-adalimumab-biosimilar-from-Fujifilm-Kyowa-Kirin-Biologics
4. GaBI Online - Generics and Biosimilars Initiative. Fujifilm and Kyowa launch biosimilars joint venture [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 4]. Available from: www.gabionline.net/Biosimilars/News/Fujifilm-and-Kyowa-launch-biosimilars-joint-venture
5. 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 2018 May 4]. 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, Mylan
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