jueves, 1 de noviembre de 2018

FDA approves Hyrimoz (adalimumab-adaz), biosimilar to Humira (adalimumab) - Drug Information Update

FDA approved Hyrimoz (adalimumab-adaz) for multiple indications. Hyrimoz is administered by injection. This is the third FDA-approved biosimilar to U.S.-licensed Humira.  For more information, see the labeling at Drugs@FDA

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. For more information about biosimilar products, visit www.fda.gov/biosimilars.

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