On July 6th, the FDA approved its 28th biosimilar, HULIO (adalimumab-fkjp). The approval also represents the sixth biosimilar approved by the FDA for adalimumab (HUMIRA). The first was AMJEVITA (adalimumab-atto), approved in September 2016, and the most recent was ABRILADA (adalimumab-afzb), approved in December of 2019.
Like its reference product, HUMIRA (adalimumab), HULIO is approved a TNF inhibitor intended to treat patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.
As of yet, no adalimumab biosimilars have launched in the U.S. due to HUMIRA’s patent protection, which is set to expire in 2023.
Read more about the approval here.