December 06, 2019 — The U.S. Food and Drug Administration (FDA) today approved Avsola (infliximab-axxq), the 4th biosimilar to U.S.-licensed Remicade (infliximab).
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.
Posted: December 2019
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