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The U.S. Food and Drug Administration regulates biological products, or biologics, which have transformed the treatment of many illnesses and are the fastest-growing class of medications in the U.S. Biologics offer hope and healing to millions of Americans, but they can be expensive. In 2021 alone, the U.S. spent $256 billion on biologics. Although biologics comprise approximately 3% of prescriptions in the U.S., these products account for over half of prescription medicine spending. This is not sustainable for either the patients who need these medicines or for our health care system. That is why the FDA and the Federal Trade Commission (FTC) have been working together to help advance competition for biologics, including biosimilars and interchangeable biosimilars.
Biologics are used to treat many illnesses, including chronic skin diseases, inflammatory bowel disease, rheumatoid arthritis, kidney conditions, diabetes, macular degeneration, and cancer. Biosimilars and interchangeable biosimilars can provide greater access to biologic treatment options and potentially reduce costs for patients and the health care system through market competition.
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