FDA Proposes Revised Labeling Practices for Biosimilar Products

The Food and Drug Administration proposed a draft guidance on Friday meant to assist applicants in developing labels for their biosimilar and interchangeable biosimilar products.

A biosimilar is considered a product close enough to a biologic product used to treat patients in the same way, and interchangeable biosimilar products can be swapped out as a substitute for a biologic at the pharmacy counter. Not all biosimilar drugs are interchangeable.

When finalized, this guidance will revise and replace Labeling for Biosimilar Products from July 2018. It applies to submissions under the Public Health Service Act.

Significant changes from the previous guidance ...