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Japanese firms developing biosimilars Posted 09/11/2012

Japanese firms are definitely not dragging their heels when it comes to biosimilars. The latest agreement for biosimilar development involves LG Life Sciences (LGLS) and Mochida Pharmaceutical (Mochida), while joint venture Fujifilm Kyowa Kirin Biologics has announced it is to initiate development of a biosimilar version of bevacizumab.

South Korea-based LGLS announced on 7 November 2012 that LGLS and Japan-based Mochida had finalised an agreement to co-develop and commercialize an unspecified biosimilar in Japan.

LGLS and Mochida plan to cooperate on carrying out clinical trials for the biosimilar and on the registration of the product in both Japan and South Korea. LGLS also announced that the company has already secured an upfront and phased milestone payment for successfully developing the required biosimilar technology. LGLS received financial aid for research and development of the biosimilar from the South Korean Ministry of Knowledge Economy in 2010.

LGLS expects the agreement to accelerate entry and commercialization of its biosimilar into both the Japanese and South Korean pharmaceutical markets. LGLS will supply the final products, which will be manufactured in its Osong facility, to both Japan and South Korea.

Mochida also has biosimilar agreements in place with Japan-based Fuji Pharma and Budapest-based Gedeon Richter. In fact, Mochida and partner Fuji Pharma already filed respective applications for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan in November 2011 [1].

Meanwhile, on 24 October 2012, the biosimilars joint venture Fujifilm Kyowa Kirin Biologics announced that it is to initiate development of a biosimilar version of bevacizumab, an anti-VEGF humanised monoclonal antibody, which is used to treat cancers such as colorectal cancer.

The joint venture, which was set up between Japanese digital camera maker Fujifilm and biotech firm Kyowa Hakko Kirin in November 2011, plans to start clinical trials for the bevacizumab biosimilar in 2014.

This will be the second biosimilar for the company, as it is already developing a biosimilar of the fully human anti-TNF-alpha monoclonal antibody, adalimumab, which is used for treatment of rheumatoid arthritis. Fujifilm Kyowa Kirin Biologics expects to start clinical trials for its adalimumab biosimilar in Europe in the first half of 2013.

Fujifilm is also involved in contract manufacturing for the biologicals industry via its Fujifilm Diosynth Biotechnologies subsidiary. The US/UK-based firm announced on 24 October 2012 that it had entered into a strategic alliance with Piramal Healthcare UK, whereby the two parties will offer contract development and manufacture of antibody drug conjugates, which may also include biosimilars.

Japan is a lucrative market and it is not surprising that it is also attracting the attention of biosimilars developers. It is currently the world’s second largest pharmaceutical market, surpassed only by the US, and was valued at US$96 billion in 2010 [2].

Related articles

Fujifilm and Kyowa launch biosimilars joint venture

Fujifilm and Kyowa Hakko Kirin in biosimilars joint venture

Partnerships will drive biosimilar development

Gedeon Richter sign biosimilars’ agreement with Mochida

References

1.  GaBI Online - Generics and Biosimilars Initiative. First biosimilar G-CSF in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Nov 9]. Available from: www.gabionline.net/Biosimilars/News/First-biosimilar-G-CSF-in-Japan

2.  GaBI Online - Generics and Biosimilars Initiative. Japanese government promoting generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Nov 9]. Available from: www.gabionline.net/Generics/News/Japanese-government-promoting-generics

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Source: Fujifilm Diosynth Biotechnologies, Fujifilm Kyowa Kirin Biologics, LG Life Sciences

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