New draft guidance on biosimilar product labeling issued by US FDA

The US Food and Drug Administration has issued draft new guidance it will give to industry on the labeling of biosimilar products.

This has been published to give the chance for all interested parties – companies, health care providers and patients - to have their say on what is a highly important issue, as labeling communicates a product’s safety and effectiveness to the practitioners who decide whether it is appropriate for patients.

The new guidelines are aimed at ensuring that “new, safe and effective health care options become available for patients”, according to Leah Christl, associate director for therapeutic biologics in the Office of New Drugs in the FDA's Center for Drug Evaluation and Research.