What's New

October 24, 2012
FUJIFILM Corporation
Kyowa Hakko Kirin Co., Ltd.

FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd (President and CEO: Hideaki Nomura; hereinafter "Fujifilm Kyowa Kirin Biologics"), a joint venture between FUJIFILM Corporation (President and COO: Shigehiro Nakajima; hereinafter "Fujifilm") and Kyowa Hakko Kirin Co., Ltd. (President and CEO: Nobuo Hanai, hereinafter "Kyowa Hakko Kirin") announced today that it will endeavor to develop a biosimilar version of bevacizumab, an anti-VEGF(*) humanized monoclonal antibody which has impressive therapeutic effects for cancers such as colorectal cancer and non-small cell lung cancer(*2).

Fujifilm Kyowa Kirin Biologics is a fifty-fifty joint venture between Fujifilm and Kyowa Hakko Kirin, launched on March 27, 2012 for the development, manufacture and marketing of biosimilars. Presently the company is developing a biosimilar of the fully human anti-TNF-α monoclonal antibody, adalimumab, a drug with dramatic therapeutic effects for rheumatoid arthritis, and is proceeding with preparations to begin clinical trials in Europe in the first half of 2013.

Fujifilm Kyowa Kirin Biologics intends to develop the biosimilar version of bevacizumab as the second drug in their lineup. After introducing the production cell line(*3) already produced by Kyowa Hakko Kirin, Fujifilm Kyowa Kirin Biologics plans to start clinical trials in 2014.

By merging the technologies in advanced production, quality control and analysis which Fujifilm has developed over many years through its photographic film business, with the proprietary technologies and know-how which Kyowa Hakko Kirin has accumulated through its biopharmaceutical R&D and manufacturing, Fujifilm Kyowa Kirin Biologics intends to create revolutionary production processes and reduce costs for the production of biosimilars. Through this partnership, the company will develop and manufacture reliable, high quality, cost-competitive biosimilar products and commercialize these products in a timely manner. With this strategy, Fujifilm Kyowa Kirin Biologics aims to hold a leading position in the expanding biosimilar market.

1 VEGF is an abbreviation for vascular endothelial growth factor. VEGF is a glycoprotein which promotes mitogenic activity in vascular endothelial cells, which in turn stimulates angiogenesis.
*2 Lung cancer can be broadly divided into small cell lung cancer and non-small cell lung cancer, with 85% of lung cancers falling into the latter category. Non-small cell lung cancers include squamous cell cancer, adenocarcinoma and large cell carcinoma.
*3 A production cell line is a cell line used for the manufacture of biopharmaceuticals. The cell line has been transfected with the genes for bevacizumab and is used to produce biosimilar bevacizumab.