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FDA Issues Draft Guidance for Labeling of Biosimilars
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The FDA has issued a new draft guidance which recommends biosimilar labeling that differentiates biosimilar products from their reference drugs.
According to the draft guidance, a biosimilar product name should be used in labeling text that is specific to the biosimilar product or refers solely to the biosimilar product. The FDA recommends the proprietary name be used for biosimilar products with proprietary names. If a proprietary name is unavailable for the biosimilar, then the proper name of the biosimilar should be used. The FDA also recommended to specifically identify the branded biologic upon which the biosimilar is based.
The FDA also recommended that biosimilar labeling incorporate relevant information from the reference product labeling, with appropriate product-specific modifications. The relevant information from the reference product labeling that should be incorporated into the biosimilar labeling depends on whether the applicant seeks approval for all or fewer of the conditions of use for the reference product.
According to a statement released from the American College of Rheumatology (ACR), the ACR supports additional measures that provide physicians with information to assess the safety and efficacy of the biosimilar product.
“Biosimilar naming is a topic of great importance to the rheumatology community, since many of our patients rely on the administration of safe and effective biologic therapies to manage their chronic conditions. Physicians must be able to confidently prescribe these therapies to patients and know that proper mechanisms are in place to allow rheumatologists to monitor patients’ responses and reactions to biosimilars,” according to the statement.
The ACR added, “We believe that the clinical trial data for the biosimilar should be included in the labeling, and that the label should specify whether the supporting clinical data for each indication are derived from studies of the biosimilar or the reference biologic. The ACR will continue to review the FDA’s draft guidance and submit detailed comments in the coming weeks. We look forward to continued dialogue with the FDA as the agency works to bring safe and effective biosimilars to market.”
References:
www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm493439.pdf