The 50:50 joint venture between the two companies for the development, manufacturing and sales of biosimilars was first announced in November 2011 [1] and is called Fujifilm Kyowa Kirin Biologics. The venture aims to merge Fujifilm’s advanced production, quality control and analysis technology developed through its photographic film business, with Kyowa’s proprietary technologies and know-how, accumulated through its biopharmaceutical R & D and manufacturing. It is hoped that the partnership will ‘create revolutionary production processes and achieve cost reduction for biosimilars’, with the lofty goal of becoming the market leader.

Fujifilm has already announced that this joint venture further reinforces the foundation of its biopharmaceutical business and that the company aims to start a clinical trial for its first biosimilar candidate by 2013 [1].

The initial focus for Fujifilm Kyowa Kirin Biologics will be the development of a biosimilar of Abbott’s rheumatoid arthritis drug Humira (adalimumab). The joint venture plans to start clinical trials in the beginning of 2013 and aims for market introduction four to five years after the start of clinical trials.

Adalimumab is a human-derived, genetically-engineered monoclonal antibody. The product acts to reduce excessive levels of human tumour necrosis factor (TNF) alpha, which plays an important role in abnormal inflammatory and immune responses. It therefore acts as an anti-TNF therapy, which is approved by EMA for the treatment of psoriasis and Crohn’s disease, as well as rheumatoid arthritis.

Abbott has much to lose when biosimilars of Humira hit the market after patent expiry in 2016. The arthritis treatment had worldwide sales of a whopping US$5.7 billion in 2010, making it one of the top 10 best-selling medications [2].

Fujifilm Kyowa Kirin Biologics also plans to start clinical trials of one biosimilar every year after 2014 and intends to hold talks with other companies for biosimilar collaborations.

Fujifilm has diversified into the pharmaceutical business as one of its focal areas for future growth and also set up a joint venture with India-based Dr. Reddy’s in July 2011.

Despite high development costs, biosimilars are set to become a big part of the future of the pharmaceutical industry. According to 2011 data from Datamonitor, the global biosimilars market is expected to reach US$3.7 billion in 2015, compared to US$243 million in 2010 [3].

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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 2012 Mar 30]. Available from: www.gabionline.net/Biosimilars/News/Fujifilm-and-Kyowa-Hakko-Kirin-in-biosimilars-joint-venture

2.  GaBI Online - Generics and Biosimilars Initiative. The market for global and European biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Mar 30]. Available from: www.gabionline.net/Biosimilars/Research/The-market-for-global-and-European-biosimilars

3.  GaBI Online - Generics and Biosimilars Initiative. Stada and Richter to collaborate on biosimilar development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Mar 30]. Available from: www.gabionline.net/Biosimilars/News/Stada-and-Richter-to-collaborate-on-biosimilar-development