US FDA's draft biosimilar labeling guidance falls short on patient safety measures, says AfPA

A critical response has been given to draft new guidance issued by the US Food and Drug Administration on the labeling of biosimilars by the Alliance for Patient Access (AfPA).

This group is a network of physicians who work to ensure patient access to approved therapies, and it has been quick to comment after the FDA last week invited feedback on its recommendations for the new labeling of biosimilar products.

Labeling is important in communicating a product’s safety and effectiveness to the practitioners who decide whether to prescribe it to patients.