Labeling for Biological Products is the final version of a draft guidance for industry originally released in March 2016. The recommendations pertain primarily to the prescribing information (i.e., package insert), except for certain recommendations pertaining to FDA-approved patient labeling. The guidance does not provide specific labeling recommendations for interchangeable products (although these may be provided in future guidance).
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—FDA recommends that biosimilar product labeling incorporate relevant safety and effectiveness data and information from the reference product labeling, with appropriate product-specific modifications. Information and data from a clinical study of a proposed biosimilar product should be described in its labeling only when necessary to inform safe and effective use by a health care practitioner.
In general, if a biosimilar product has a proprietary name, the proprietary name (e.g., NEXSYMEO) should be used in the appropriate sections.
FDA recommends including a statement in the “Highlights” section of labeling that should read 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.
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:
*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of [BIOSIMILAR PRODUCT’S PROPRIETARY NAME] has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.