Draft Guidance for Industry on Labeling for Biosimilar Products

Labeling for Biosimilar Products is a draft guidance for industry intended to assist in the development of labeling (i.e., the prescribing information or “package insert” plus any patient-directed information) for proposed biosimilar products. Because the goal of a biosimilar development program is to demonstrate biosimilarity between the proposed product and the reference product—not to independently establish the safety and effectiveness of the proposed product—the draft guidance recommends incorporating relevant safety and effectiveness data and information from the reference product labeling, with appropriate product-specific modifications. Data from clinical studies designed to support a demonstration of biosimilarity should be included only when necessary to inform safe and effective use of the biosimilar product by a health care practitioner.

The draft guidance also proposes including a “Biosimilarity Statement” in the “Highlights” section of labeling, with text as follows:

[BIOSIMILAR PRODUCT’S PROPRIETARY NAME (biosimilar product’s proper name)] is biosimilar* to [REFERENCE PRODUCT’S PROPRIETARY NAME (reference product’s proper name)] for the indications listed.

For example:

NEXSYMEO (replicamab-cznm) is biosimilar* to JUNEXANT (replicamab-hjxf) for the indications listed.

The asterisk would correspond to a standard footnote defining the term biosimilar.

The full document is available on the FDA website.