FDA Approves Abrilada
The U.S. Food and Drug Administration (FDA) approved Abrilada (adalimumab-afzb), the 5th biosimilar to U.S.-licensed Humira (adalimumab). This approval marks the 25th biosimilar.
A biosimilar is a biological product that is highly similar to an existing FDA-approved biological product, known as a reference product. The biosimilar must also have no clinically meaningful differences in terms of safety and effectiveness from the reference product. All FDA-approved biosimilar products meet the FDA’s strict standards for approval. Patients and healthcare providers can rely on the safety and effectiveness of the biosimilar or interchangeable product just as they would for the reference product.
November 22, 2019