FDA Issues Draft Guidance for Biosimilar Products Labeling

The FDA has announced the availability of a draft guidance for industry entitled “Labeling for Biosimilar and Interchangeable Biosimilar Products.” The guidance is intended to help applicants develop draft labeling for proposed biosimilar and interchangeable biosimilar products for submission in an application under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)) (351(k) application).

In the new guidance, the FDA recommends that biosimilar and interchangeable biosimilar product labeling incorporate relevant data and information from the reference product labeling, with appropriate modifications. The relevant data and information from the reference product labeling that should be incorporated into the biosimilar and interchangeable biosimilar product labeling will depend on whether the applicant is seeking licensure for all conditions of use or fewer than all conditions of use for which the reference product has been previously licensed.

In addition, biosimilar and interchangeable biosimilar product labeling may include information specific to the product that is necessary to inform safe and effective use, including preparation, administration, and storage conditions. This information may differ from that of the reference product labeling to reflect differences between the biosimilar or interchangeable biosimilar product and the reference product.

The updated guidance will not impact pharmacy-level substitution of interchangeable biosimilar products. Not including an interchangeability statement in the product’s Prescribing Information does not change the status of the product or mean that the product is not interchangeable.

Because interchangeability pertains to pharmacy-level substitution, the FDA believes it is more appropriate to include information about interchangeability in the Purple Book, which may be easier to use as a pharmaceutical reference, rather than in product labeling, which is prescriber-focused.