Pharmacy Times May 25, 2023
It is Celltrion’s first biosimilar and the second anti-TNFα biosimilar approved for use in the US.
The FDA has approvedadalimumab-aaty (Yuflyma; Celltrion USA), a high concentration and citrate-free formulation of adalimumab (Humira; Abbvie) biosimilar.
The 100 mg/mL strength was approved for the treatment of 8 conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.
“[Adalimumab-aaty] offers patients a high-concentration and citrate-free formulation of adalimumab biosimilar, providing an alternative treatment option for patients. It represents a key treatment option in patient care and patient choice,” Tom Nusbickel, chief commercial officer at Celltrion USA, said in a press release.
Adalimumab-aaty is Celltrion’s first biosimilar and the second anti-tumor necrosis...