In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars. Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy without intervention of the prescribing health care provider.
On May 23, Celltrion announced that the FDA granted an expanded interchangeability designation for YUFLYMA® (adalimumab-aaty), Celltrion’s biosimilar to AbbVie’s HUMIRA®. The expanded designation applies to 40mg prefilled syringes and 40mg & 80mg autoinjectors. Following the FDA’s previous interchangeability designation for 20mg & 80mg prefilled syringes, YUFLYMA is now fully interchangeable with HUMIRA across all marketed dosage forms and strengths.
On May 27, Samsung Bioepis (“Samsung”) and Organon also announced that the FDA granted interchangeability designation for their HUMIRA biosimilar, HADLIMA® (adalimumab-bwwd). The FDA granted the designation for HADLIMA high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringes. HADLIMA was previously granted interchangeable status in June 2024 for low-concentration (40 mg/0.8 mL) prefilled syringes and single-dose vials. HADLIMA is now interchangeable with all presentations of HUMIRA.
Like HUMIRA, YUFLYMA and HADLIMA are approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
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