First Adalimumab Biosimilar Gains Approval in Japan

Fujifilm Kyowa Kirin Biologics said it has received Japanese regulatory approval to manufacture and market the first adalimumab biosimilar in the island country.

The company said the approval was received June 29 for the product, which was identified as Hulio. It references AbbVie’s Humira.

The product is indicated for rheumatoid arthritis, psoriasis vulgaris, arthritic psoriasis, pustular psoriasis, ankylosing spondylitis, entero-behcet’s disease, Crohn disease, and polyarticular-course juvenile idiopathic arthritis.

Fujifilm Kyowa Kirin Biologics said it partnered with Mylan in 2018 to commercialize the product in Europe and expand sales across the globe. To date the product is available in 20 countries in Europe, and Fujifilm Kyowa Kirin Biologics is working to obtain marketing approvals in other countries.

"We are proud to be a leader by providing the first adalimumab biosimilar in Japan," said Atsushi Matsumoto, Fujifilm Kyowa Kirin Biologics president and CEO.

The biologics company was established by Fujifilm and Kyowa Kirin in 2012 for the purpose of developing, manufacturing, and marketing biosimilars. Its pipeline includes a biosimilar for the anti-VEGF humanized monoclonal antibody bevacizumab, which is used for colorectal and non—small cell lung cancers.

Biosimilar market growth in Japan has been described as slow but poised for growth. The biosimilar market in Japan grew by 25% a year from 2015 to 2017, which was slow compared with worldwide market growth of 72%, according to a McKinsey report last year. Although “in 2017 Japan’s biologics market accounted for 13% of the worldwide market, excluding the United States, its biosimilar market, valued at $140 million, accounted for just 5%,” the report said.

McKinsey explained that the Japanese co-pay system can make the originator product cheaper for patients than the biosimilar, which it said was the chief reason why biosimilars have not taken root at a faster pace in Japan.

One of the most recent new launches in Japan in 2018 when Daiichi Sankyo began marketing a biosimilar trastuzumab.