FDA issues draft biosimilars labeling guidance

Labeling is an important aspect of the U.S. Food and Drug Administration (FDA) prescription drug approval process. FDA-approved prescription drug labeling is the most authoritative mechanism for communicating information about a medicine’s safety and effectiveness to health care providers.  The labeling summarizes key scientific information about a medicine needed by health care providers to assess its benefit-risk profile and determine if the medicine is appropriate for use in treating an individual patient.

Recently, the FDA issued a draft guidance outlining proposed requirements for labeling of biosimilar medicines.  Biosimilars are biologics that are “similar” to another biologic drug already approved by the FDA (i.e., the reference product). 

While PhRMA continues to review the draft guidance, we look forward to providing comments to FDA to help ensure the Agency’s final biosimilar labeling guidance facilitates patient-centric prescribing and choice.

An approach to biosimilar labeling that provides regulatory transparency to support informed choices by health care professionals and patients is key. As such, biosimilar labeling should incorporate the following three elements:

1. State that the product has been approved as a biosimilar for stated indications and routes of administration and identify the reference product;

2. Describe the basis of approval for each indication by identifying the relevant data for the reference product and biosimilar that support a finding of biosimilarity; and,

3. State whether or not FDA has made a determination of interchangeability with the reference product and include any such FDA finding.

Working with all stakeholders to establish a mature, science-based regulatory framework that addresses outstanding questions, such as labeling, naming and interchangeability is a priority for PhRMA and we look forward to continued engagement with the FDA on this important topic for patient health.

Click here for more information on PhRMA’s views on biosimilars labeling.