FDA takes action to remove biosimilars roadblock

In a move expected to facilitate the entry of biosimilar drugs into the US market, the US Food and Drug Administration (FDA) has proposed a system for naming such copycat versions of biological drugs. Under the FDA’s plan, the generic name would be retained and four random letters would be added at the end to provide a unique identifier.

The FDA said that its proposal would help prevent medical errors caused by the inadvertent substitution of biological products that have not been determined to be interchangeable, and also facilitate the tracking of adverse events associated with biological products. The agency approved its first biosimilar back in March.

The Biotechnology Industry Organisation (BIO) and the Biologics Prescribers Collaborative (BPC), an affiliation of groups representing physicians who regularly prescribe biologics, both applauded the FDA’s proposal. The organisations agreed with FDA that assigning distinguishable product names for all biological products will help to prevent inappropriate substitution, facilitate postmarket surveillance of drug safety, ensure accurate attribution of adverse events to the right product, and support tracing of products in the event of the need to recall.

However, Bertrand Liang, who chairs the US Generic Pharmaceutical Association’s Biosimilars Council, warned that the FDA’s proposal warrants ‘serious scrutiny’ because of its potential to ‘erect barriers to patient access to new, more affordable medicines, and jeopardise their safety’.