Definition

A biological drug that is very much like another biological drug (called the reference drug) that has already been approved by the U.S. Food and Drug Administration (FDA). Biosimilar drugs and reference drugs are made from living organisms but they may be made in different ways and of slightly different substances. To be called a biosimilar drug, a biological drug must be shown to be as safe as, work as well as, and work in the same way as its reference drug. It must also be used in the same way, at the same dose, and for the same condition as the reference drug. Biosimilar drugs must be approved by FDA, and may cost less than the reference drugs.