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Biosimilar

A near copy of a biologic medicine, approved as having no meaningful clinical difference.

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What does Biosimilar mean?

A biosimilar is a medicine that is highly similar to an already approved biologic (a drug made from living cells, such as an antibody or insulin) with no clinically meaningful differences in safety and effectiveness, as defined by regulators such as the US FDA and the European Medicines Agency. Unlike a generic copy of a simple chemical drug, it cannot be an exact copy, so development is slower and costlier, and prices usually fall less. Example: if a biologic sells at 1,000 a dose, a biosimilar might launch at a 30 percent discount, at 700, rather than the much deeper cuts common with generics. Uptake depends on doctors, payers and the rules on substitution.

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