Draft Guide on Biosimilar/Interchangeable Labeling

FDA has issued a draft guidance entitled “Labeling for Biosimilar and Interchangeable Biosimilar Products.” The agency says the document’s recommendations for biosimilar and interchangeable biosimilar product labeling pertain only to the prescribing information, except for certain recommendations in Section V (FDA-Approved Patient Labeling of Biosimilar and Interchangeable Biosimilar Products), which pertain to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, Instructions for Use).

FDA notes that in the eight years since it approved the first biosimilar product, it has gained valuable insight into “labeling considerations” for biosimilar and interchangeable biosimilar products, including labeling statements in the Highlights of the Prescribing Information section that explain biosimilarity and interchangeability. Because products first approved were considered biosimilar and not interchangeable, and then subsequently an interchangeability status may be granted, it has been a challenge to “determine how to appropriately label such products and keep labeling up to date without causing undue confusion,” it says.

“Moreover,” FDA continues, “a labeling statement noting that certain products within a 351(k) BLA have been approved as interchangeable, and explaining the interchangeability standard, is not likely to be useful to prescribers, who can prescribe both biosimilar and interchangeable biosimilar products in place of the reference product with equal confidence that they are as safe and effective as their reference products.” Additionally, FDA has determined that its Purple Book is the best resource for pharmacists and other healthcare professionals to keep up to date on information about interchangeability rather than labeling.

“Consistent with this evolution in our thinking, the draft guidance states that both biosimilar and interchangeable biosimilar products should contain the same biosimilarity statement in the Highlights of the Prescribing Information,” FDA concludes. “This statement is applicable to biosimilar and interchangeable biosimilar products.” Accordingly, the agency has revised a draft guidance entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act” to reflect this change in the interchangeability statement.