Adalimumab Biosimilar Approval for Mylan and Fujifilm Kyowa Kirin

On July 6, the Food and Drug Administration approved partners Mylan/Fujifilm Kyowa Kirin Biologics’ biosimilar version of adalimumab for use in patients with autoimmune diseases. Officially dubbed Hulio® (adalimumab-fkjp), this 28th approved biosimilar will be first available for prescription in August 2023, based on the licensing deal Mylan signed previously, making it the fourth adalimumab biosimilar to launch.

Hulio approval

The drug was first approved in the European Union in October 2018, and has launched there. The FDA approval was partly based on the results of a phase 3 clinical trial in patients with rheumatoid arthritis, comparing Hulio with AbbVie’s reference product. The investigation found no meaningful differences in outcomes, safety profile, or immunogenicity between the agents.

According to the approved labeling, Hulio received approval for seven indications, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Interestingly, Mylan had at one point its own adalimumab candidate, MYL-1401A, which was the subject of a phase 3 trial completed in 2017. Mylan signed its agreement with Fujifilm Kyowa Kirin in time to join the European launch of Hulio, and it focused its attention on getting the latter’s adalimumab version, designated FKB327, approved in the US.

In other biosimilar news…In a case that may mirror the internationally publicized retraction of COVID-19 papers relying on a healthcare database, the results of a study in Toxicology and Applied Pharmacology are being questioned. The study claimed a higher incidence of side effects for several biosimilars available in India compared with the reference product Neupogen®, but the study methods and reliance on a specific database have been criticized.

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