On July 18, 2018, the FDA issued final guidance on “Labeling for Biosimilar Products.” The guidance provides recommendations for drafting prescribing information (i.e., the package insert) for biosimilar products, as well as certain recommendations for FDA-approved labeling (Patient Information, Medication Guide, and Instructions for Use). Stating that the goal of biosimilar development is to demonstrate biosimilarity to the reference product, rather than to independently establish safety and efficacy, the FDA recommends that biosimilar product labeling incorporate relevant data and information from the reference product labeling, including the clinical data that supported safety and efficacy of the reference product in the one or more conditions for which licensure is sought for the biosimilar product, with appropriate product specific modifications. The guidance indicates that “[t]ext based on the reference product labeling need not be identical [to that labeling] and should reflect currently available information necessary for safe and effective use of the biosimilar product,” including differences in administration, preparation, storage, or safety. Biosimilar product labeling generally should not include a description of clinical studies conducted to support biosimilarity, unless “necessary to inform safe and effective use by a health care provider” of that product.
The FDA stated that a “biosimilar product applicant generally may seek licensure for fewer than all of conditions of use for which the reference product is licensed.” The guidance indicates that a biosimilar product applicant can later seek to add additional conditions of use after biosimilar product licensure for licensed conditions of use of the reference product. The guidance suggests that there generally is no need to include information from the reference product label for carved-out conditions of use or dosage regimen(s), unless necessary to “ensure safe use”—such as where safety information is “not specific to a particular licensed indication” or not “easily extracted.” The FDA recommends that such text “should be written in a manner that does not imply that the biosimilar product is licensed for” a carved-out indication or use. The Indications and Usage section should be “specific to the licensed indications for the biosimilar product and should be consistent with information previously approved for the reference product.”
The guidance addresses product identification in biosimilar product labeling including examples of the recommended use of the biosimilar product name, the reference product name, the core name, or more than one product name. The guidance provides a specified biosimilarity statement that the FDA recommends including in in the Highlights section and an exemplary statement on immunogenicity that the FDA recommends including in the Immunogenicity subsection of the Adverse Reactions section.
The FDA noted that there is an “ongoing obligation to ensure . . . [that] labeling is accurate and up-to-date.” If new information causes product labeling to be inaccurate, false, or misleading, the biosimilar application holder “must take steps to change the content of its product labeling.”
The FDA stated that specific recommendations for labeling for interchangeable products will be provided in future guidance. Readers are encouraged to review the final guidance, also available on FDA’s website.