FDA Issues Draft Guidance on Biosimilar Labeling

Following months of pressure from industry, the FDA has released draft guidance on biosimilars labeling, recommending that sponsors incorporate into product labeling information from the reference product labeling.

Labeling for package inserts should include a description of the clinical data that supported safety and efficacy of the reference product and should be specific to the conditions of the reference product for which the applicant is seeking approval, the agency says in guidance released last week.

Drugmakers, however, should not include information from clinical studies of the proposed biosimilar. That could cause prescriber confusion, the agency says, noting that a clinical trial of the biosimilar could be using different endpoints from the ones used to measure the reference product. Sponsors should only include such data to inform safe and effective use by a healthcare practitioner.