Japanese biosimilar guidelines based on the EU’s existing processes were published by the Ministry of Health, Labor and Welfare in March 2009. With these guidelines, the world’s second largest pharmaceutical market became ready for biosimilar competition.
REGISTRATION OF BIOSIMILARS
We have recently published the information about the Japanese guidelines but when we have a detailed look, we see that, the guidelines for biosimilars allow abbreviated clinical and non-clinical studies if the similarity with the reference drug can be shown at early stages.
Besides, Japan, which has one of the most strong pharmacovigilance systems in the world, requires reporting for all patients every 2 weeks till the end of the 6th month of approval of biosimilars.
Normally, due to local law, pharmaceutical companies should conduct clinical trials with the Japanese population but for biosimilars, there is an exception: sometimes, patient data from other Asian countries can be accepted by the regulatory body in Japan.
Other regulatory requirements, like efficacy, safety, stability studies are the same with originators which makes Japan a highly regulated market for biosimilars.
According to Japanese pricing regulations, biosimilars can get 70% of the reference product’s price. But, due to the high amount of expenditures during the development of biosimilars, these products can get an exception of 10% price increase.
2 APPROVED & MORE TO COME
Japan is the second largest market for pharmaceuticals valued at $96 billion in 2010 with a relatively low rate of generic penetration of 23%1. The growing and aging population makes it attractive for biosimilar manufacturers; not only for the local, but also for the global players like Sandoz…
Sandoz, is again the leading company for biosimilars. Like in the EU and US, somatropin Sandoz is the first biosimilar which was approved in September 2009. Sandoz has 2 more approved biosimilars in the EU, epoetin alfa and filgrastim but they are not approved in Japan yet2.
The second company was JCR, Japan Chemical Research Pharmaeuticals and they got the approval for epoetin alfa biosimilar in January 2010. JCR co-developed this product with Kissei Pharmaceutical Company and it was launched in May 20103. As well known, epoetin alfa is indicated for renal anemia on dialysis and the generic name of this product is “epoetin kappa” in Japan.
Teva, the Israeli generics company is also trying to increase its presence in Japan and in May this year, they have bought a majority stake in Taiyo Pharmaceutical Industry1. Teva has marketed biosimilars like filgrastim, somatropin and epoetin but they are also developing monoclonal antibodies like rituximab and none of them are approved in Japan yet.
Celltrion, the South Korean biosimilar company has also made a step to launch their products in Japan4. Celltrion has a wide product range5 and for two of them, trastuzumab and infliximab, they have already signed a deal with Nippon Kayaku to market these products in Japan.
This situation mirrors that although the generic uptake is low, the global biosimilar manufacturers are highly interested in Japanese market. If we think about the local players, it is clear that Japanese market for biosimilars will be more interesting in the future.
1-Wall Street Journal, May 16 2011
2- A biosimilar manufacturer: Sandoz @BiosimilarNews
5- A biosimilar manufacturer: Celltrion @BiosimilarNews