The U.S. Food and Drug Administration plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost generic drugs, biosimilars and interchangeable biologics.
Today, the FDA is taking a significant action that will help promote competition in the biologic market by providing final guidance on the pathway for “interchangeable” biologics, which may be substituted without the involvement of the prescriber, similar to how generic drugs are routinely substituted for brand name drugs when they are prescribed for patients. Biologics provide important treatment options for patients with serious diseases like cancer, rheumatoid arthritis, diabetes and multiple sclerosis. The FDA’s final guidance on interchangeability will provide clarity for developers who want to
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