New FDA Approvals: FDA Grants Interchangeability to Two Yuflyma Strengths

May 08
May 08, 2025

April 7: The FDA granted interchangeable status to Celltrion, Inc.’s Yuflyma (adalimumab-aaty) for its 20 mg/0.2 mL prefilled syringe and 80 mg/0.8 mL PFS and PFS with safety guard for its nine indications: the treatment of (1) adults with moderately to severely active rheumatoid arthritis, (2) people at least 2 years old with moderately to severely active juvenile idiopathic arthritis, (3) adults with active psoriatic arthritis, (4) adults with active ankylosing spondylitis, (5) people at least 6 years old with moderately to severely active Crohn’s disease, (6) adults with moderately to severely active ulcerative colitis, (7) adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate, (8) adults with moderate to severe hidradenitis suppurativa and (9) adults with noninfectious intermediate and posterior uveitis and panuveitis. The agency first approved the biosimilar of AbbVie Inc.’s tumor necrosis factor (TNF) blocker Humira (adalimumab) on May 23, 2023. The company tells AIS Health that it “anticipate[s] that the 40 mg dosage will also receive interchangeability approval following the expiration of exclusivity in the coming months.” Dosing via subcutaneous injection varies depending on the indication. The unbranded version of the drug is priced at an 85% discount to Humira’s wholesale acquisition cost, which is around $7,000 for two autoinjectors, and the branded version is priced at a 5% discount to Humira’s WAC.
Read more
© 2025 MMIT

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.