Another high-concentration Adalimumab Biosimilar approved by the FDA

The US Food and Drug Administration (FDA) has given the green light to the citrate-free version of adalimumab-adbm subcutaneous injection in higher concentrations. This new formulation, with a concentration of 100 mg/mL, cuts injection volume by 50% and is accessible in prefilled syringes or autoinjectors.

Adalimumab-adbm treats a range of conditions in adults. It includes moderate to severe rheumatoid arthritis, chronic plaque psoriasis, hidradenitis suppurativa, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis and various types of uveitis. It is also approved for juvenile idiopathic arthritis in young children aged 2 and older, and Crohn's disease in individuals aged 6 and older.

Adalimumab-adbm as low-concentration was introduced last year and was the first adalimumab biosimilar to receive an interchangeability designation, allowing pharmacists to substitute it for the reference product without the prescriber's intervention. However, the higher concentration of this biosimilar has not been granted this designation as of now.