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FDA Finalizes Guidance on Labeling for Biosimilars


The FDA has finalized its guidance on labeling of biosimilar products, and FDA Commissioner Scott Gottlieb, MD, called the finalized guidance "one of a suite of deliverables" that will be unveiled as part of the Biosimilars Action Plan.

The FDA has finalized its guidance on labeling of biosimilar products. The guidance pertains to prescribing information, but it does not provide specific recommendations on labeling interchangeable biosimilars.

In the guidance, the agency reiterated its position that a finding of safety and effectiveness for the reference product can be relied upon to give healthcare providers the information they need to make prescribing positions. As such, biosimilars should include relevant data (which will depend on the indication of use, dosing regimen, and conditions of use) from the reference product in their labeling. However, the guidance states that the labeling should not include a description of data from clinical studies used to support biosimilarity, as such studies are not designed to demonstrate safety or effectiveness and their inclusion could be misinterpreted in the context of a drug label.

While the biosimilar’s label should be based on that of the reference product, the guidance indicates that the text of the labels does not have to be identical; by law, a biosimilar’s label must meet the requirements of the physician labeling rule and the pregnancy and lactation labeling final rule, while the reference product may not have been bound by those rules at the time of its approval. Additionally, a biosimilar’s label may have additional information specific to the product (such as administration or storage information) that does not apply to the reference. Labeling for the biosimilar should be specific to the conditions of use in order to help ensure safe use.

In terms of identifying the biosimilar in the label, the guidance recommends that the biosimilar’s proprietary name be used in text that is specific to the product itself, such as indications and usage, dosage and administration, description, and handling information. If the biosimilar has no proprietary name, or if a reference is made to the drug substance in general, the product name (the drug name plus its 4-letter suffix) should be employed instead. The proprietary name can also be used in directives and recommendations, such as boxed warnings, contraindications, warnings and precautions, and drug interactions.

The reference product should be identified as the drug name plus its 4-letter suffix, typically in sections related to adverse events and clinical studies. In text related to the overall risk/benefit profile of the therapy—whether reference or biosimilar—the drug name, without the suffixes of the individual products, should be used. The FDA stresses that multiple approaches to naming may be used, and that appropriateness of product identification is the key consideration.

The FDA also recommends including a statement on the nature of biosimilarity, as well as a statement highlighting the importance of immunogenicity prior to the inclusion of immunogenicity data based on the reference product’s label.

Finally, in cases in which medication guides with instructions for use are necessary, the instructions may differ from the reference products’ only where needed to describe the biosimilar product accurately.

On Twitter, FDA Commissioner Scott Gottlieb, MD, called the finalized guidance “one of a suite of deliverables we’ll be announcing later today when we unveil our Biosimilars Action Plan” in a speech that will take place at the Brookings Institute on July 18 at 1:30 pm.

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