A biosimilar is a biological product highly similar to an approved biological product, known as a reference product, with no clinically meaningful differences in terms of safety and effectiveness. In the U.S., if a biological compound demonstrates comparable data to a U.S. Food and Drug Administration (FDA)-licensed product from analytical, preclinical and clinical studies, it will be accepted as a biosimilar after expiration of innovator patents through an abbreviated route. Interchangeable biological products are also biosimilars, but must meet additional criteria to match the reference product. Interchangeable can be substituted for the reference product without a prescription from a health care provider.
This article addresses current regulations and challenges impacting the development of biosimilars. Early awareness of changes and challenges will allow biosimilar developers to move more quickly into key markets.
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