Biosimilars Are Not Generics

June 2018

Medical oncologist Dr. Michael Morse describes the key differences between biosimilars and generic drugs. Biosimilars are often confused with generic drugs, but they are not the same.

Unlike generics, the FDA requires a biosimilar to be highly similar to the existing biologic medicine, which is referred to as a "reference product." A biosimilar can have minor differences in clinically inactive components when compared to its reference product. But, to be considered highly similar, it can't exhibit any clinically meaningful differences in safety, purity, or potency. Visit for more info.
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