The U.S. Food and Drug Administration (FDA) approved a supplemental application for Amjevita (adalimumab-atto) on April 7, 2025. This approval, designated as a supplemental efficacy application (BLA 761024 S-23), was granted to Amgen Inc. for its biosimilar adalimumab product.
Background
Adalimumab is a monoclonal antibody that targets tumor necrosis factor-alpha (TNF-alpha), a cytokine involved in systemic inflammation. It is widely used to treat various autoimmune and inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. Amjevita (adalimumab-atto) is a biosimilar to reference adalimumab (Humira). Biosimilars are highly similar to an FDA-approved reference product and have no clinically meaningful differences in terms of safety, purity, and potency. The availability of biosimilars like Amjevita provides additional treatment options and can increase patient access to important biologic therapies.
What this means
This supplemental approval for Amjevita (adalimumab-atto), specifically addressing efficacy, indicates a potential expansion or refinement of its approved therapeutic uses. For clinicians and patients, this reinforces Amjevita's role as a trusted and effective treatment option within the adalimumab class, potentially broadening the patient population that can benefit from this biosimilar. Such approvals are crucial for ensuring that biosimilars maintain comprehensive labeling consistent with their reference products, providing clarity on their full range of indications and supporting their use across various inflammatory conditions.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA) on April 7, 2025, as detailed on the accessdata.fda.gov website, referencing supplemental application BLA761024.