FDA Approves Adalimumab Biosimilar From Fujifilm Kyowa Kirin Biologics

The FDA has approved Fujifilm Kyowa Kirin Biologics's Hulio adalimumab biosimilar, making it the sixth adalimumab biosimilar approved in the United States. However, none will be launched before 2023 because of the strength of AbbVie's exclusivity rights for Humira, the reference product. Hulio launched in Europe in 2018.
Tony Hagen
July 08, 2020
The FDA has approved an adalimumab biosimilar (Hulio) from Fujifilm Kyowa Kirin Biologics, making it the sixth adalimumab biosimilar to AbbVie’s reference product Humira that has been approved and the 28th biosimilar approved by the FDA. Mylan will handle the commercialization in the United States.

AbbVie has contracted with all 6 adalimumab biosimilar developers for sequential launch dates, with Fujifilm Kyowa Kirin Biologics’s being July 31, 2023. The earliest would be Amgen’s on January 31, 2023.

Hulio is a tumor necrosis factor blocker indicated for the subcutaneous treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis. The injectable is available in prefilled single-dose pens at 40 mg/0.8 mL and in prefilled plastic syringes at the same dose or at 20 mg/0.4 mL.

Although only just approved in the United States, Hulio was launched across major European markets in October 2018, just 1 month after the European Commission (EC) issued a positive opinion for commercialization. At the time, Mylan indicated that the product launch was a significant milestone for its progress in developing a portfolio of biosimilar products. In partnership with other pharmaceutical companies, Mylan has marketed biosimilars in dermatology, diabetes, immunology, oncology, and ophthalmology.

The EC approval for Hulio applied to all 28 EU countries as well as the European Economic Area member states of Norway, Iceland, and Liechtenstein.

In the United States, the field of adalimumab biosimilars has been growing steadily and now represents the largest group of biosimilars approved for a single drug. Only trastuzumab comes close, with 5 biosimilars approved and launched. There are currently 17 biosimilars available for use or commercialized in the United States.

AbbVie’s list of patents protecting Humira numbers over 100 and has represented a formidable obstacle to biosimilar developers seeking to bring competitor adalimumab products to market in the United States. This accounts for the 2023 launch dates, enabling AbbVie to continue capitalizing on having exclusive distribution rights in the United States for what has been the world’s most profitable drug. Humira notched revenues of over $19 billion in 2019.

Two recent studies of Hulio provided evidence that the drug is equivalent to Humira for treating rheumatoid arthritis and confirmed the subcutaneous delivery method.
 

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