- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
First Adalimumab Biosimilar Gains Approval in Japan
Japanese authorities have given marketing approval for the first adalimumab biosimilar in that country.
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.
Early Success of Adalimumab Biosimilars Featured at AMCP 2025
April 5th 2025High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US, particularly in formulary-driven transitions, as shown in 2 retrospective studies presented at the Academy of Managed Care Pharmacy annual meeting (AMCP 2025).
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Adalimumab Biosimilar Switching Policy Shows Long-Term Success in IBD
February 26th 2025Patients with inflammatory bowel disease (IBD) who switched from reference adalimumab (Humira) to a biosimilar under a mandatory nonmedical switching policy maintained long-term safety, efficacy, and treatment persistence comparable to those who remained on the originator drug, according to a Canadian study.
