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4-Letter Word: US FDA's Biosimilars/Biologics Distinction

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration wants all biologics, including biosimilars, to carry a unique four-letter suffix as part of the nonproprietary names (INNs) of the active drug substance, the agency revealed on Aug. 27 in a draft guidance document and a proposed rule – giving a big win to innovator manufacturers, which have insisted on imposing distinguishable names on the copycats1,2.