HCP Live February 26, 2024
The approval was based on clinical data from 3 multicenter, randomized trials which demonstrated the safety, efficacy, and biosimilarity of adalimumab-ryvk compared with the reference product.
The US Food and Drug Administration (FDA) has approved adalimumab-ryvk (Simlandi), the first interchangeable, high-concentration, citrate-free biosimilar to adalimumab (Humira), according to a press release published by Alvotech and Teva Pharmaceuticals.1 The tumor necrosis factor (TNF) inhibitor is approved for the treatment of a variety of autoimmune conditions, including rheumatoid arthritis (RA), juvenile idiopathic arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, uveitis, and hidradenitis suppurativa.
The product will qualify for interchangeable exclusivity for the 40 mg/.4 ml injection. Interchangeability allows pharmacists to substitute biosimilars for the originator without prescriber permission,...
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