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Celltrion's YUFLYMA® (Adalimumab-Aaty) Receives FDA Interchangeability Designation for All Its Approved Dosage Forms and Strengths
- On May 21, 2025, Celltrion, Inc. Announced that the FDA granted an expanded interchangeability designation for YUFLYMA, covering all marketed dosage forms and strengths, including 40mg prefilled syringes and autoinjectors.
- This expanded interchangeability approval follows previous clearance for 20mg and 80mg prefilled syringes and is supported by a study whose findings were shared in September 2024 during a dermatology and venereology conference held in the Netherlands.
- YUFLYMA is a biosimilar to Humira formulated without citrate at a high concentration, authorized for treating various inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease , plaque psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis in patients aged 2 years and above.
- The expanded interchangeability status of YUFLYMA arrives at a crucial moment as Celltrion remains a key player in the advancing biosimilar market. To support better patient access, the company has implemented a strategic reduction in the wholesale acquisition cost, lowering the price to $948 per syringe.
- The expanded interchangeability and price reduction align with recent federal initiatives to lower drug costs and demonstrate Celltrion USA's commitment to improving U.S. Patients' access to innovative biologics.
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66 Articles
Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths
YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1]Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled syringes (20mg & 80mg); Expanded interchangeability (IC) designation applies to prefilled syringe (40mg) and autoinjectors (40mg and…
Celltrion's YUFLYMA ® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths - Finnoexpert
Celltrion's YUFLYMA ® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths Source link The post Celltrion's YUFLYMA ® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths first appeared on Finnoexpert.
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