FDA Biosimilar Product Labeling Guidance

FDA has issued a guidance, Labeling for Biosimilar Products, to help applicants develop draft labeling for proposed biosimilar products for submission in a 351(k) application. The document says its recommendations for prescription drug labeling pertain only to the prescribing information (package insert) except for certain recommendations pertaining to FDA-approved patient labeling such as patient information, Medication Guide, and instructions for use. The guidance does not provide specific recommendations for interchangeable products.

The document includes an Introduction, Background, General Principles for Draft Labeling of Proposed Biosimilar Products, Specific Recommendations on Content of Biosimilar Product Labeling, FDA-Approved Patient Labeling, Revising Biosimilar Product Labeling, How to Submit Initial and Revised Labeling, and Interchangeable Products.