A biologic drug that closely resembles another biologic drug (called a reference drug) has been approved by the U.S. Food and Drug Administration (FDA). Biosimilars and reference drugs are made from living organisms, but they can be made in different ways and froms lightly different substances. To qualify as a biosimilar, a biologic drug must demonstrate that it is safe, works well, and functions like its reference drug.The drug should also be administered in the same manner, in the same dose and condition as the reference drug. A biosimilar drug must be approved by the FDA and may cost less than a reference drug.


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