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For the first time, U.S. regulators have approved an interchangeable, biosimilar version of Humira, a hugely popular medicine used to treat rheumatoid arthritis, among other ailments. But the extent to which the approval might make a real difference to the U.S. health care system is uncertain, because availability is a long way off and the dosing regimen may not be competitive.

On paper, the move — which confers interchangeability on a Boehringer Ingelheim biosimilar treatment — certainly appears significant.


For one, biosimilars are nearly identical variants of pricey brand-name biologic medicines that yield the same health outcomes, but may be priced at 20% to 30% less, although this does not reflect discounting. Moreover, interchangeability makes it possible that a biosimilar can be substituted for the brand-name biologic at pharmacies, a key step in building confidence for switching among medicines.

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