A July 14th FiercePharma article noted Amgen got a step closer to their first biosimilar approval in the US with unanimous support from an FDA advisory committee. The drug is a knockoff of Humira, the world’s best selling drug, and is one of nine biosimilars included in a deal struck between California-based biotech, Amgen, and Japan’s Daiichi Sankyo. Financial terms of the deal weren’t announced, but it specifies Amgen will be responsible for drug development and manufacturing, while Daiichi Sankyo handles sales and distribution in Japan.
The deal comes at the perfect time, since the Japanese government is on a campaign to build the share of generic drugs on the market to 60%. This would bring Japan, one of the largest drug markets in the world, up closer to the levels of Western countries. However, Daiichi will face competition in Japan as Nichi-Iko just bought Sagent and their pipeline of biosimilars, which will eventually hit both US and Japanese markets.