April 5, 2017

FDA Pleases No One With Final Guidance On Naming of Biologicals and Biosimilars

From: P&T Community

Stephen Barlas

The Food and Drug Administration (FDA) has put one more piece of the biosimilar puzzle in place by issuing final guidance on naming of biological innovator products and bio-similars.1 The agency hewed close to the thinking it first noted in an August 2015 proposed rule and guidance that would “name” a biosimilar by using its non-proprietary name separated from a random four-letter suffix by a hyphen.2,3 That format satisfied almost no one, and brand-name and generics manufacturers, as well as pharmacy groups, got almost none of the changes they requested.

The American Society of Health-System Pharmacists (ASHP) is particularly unhappy with the decision and asked the White House Office of Management and Budget (OMB) to stay implementation of the final guidance until its economic effects could be better studied. The ASHP argues that the addition of a suffix will force drug companies to rename the thousands of biologics now on the market, causing particular financial distress to hospitals, which would have to spend thousands of hours on information technology redesign and reprogramming.

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