Draft Biosimilar Labeling Guidance Out

FDA has published a draft guidance, Labeling for Biosimilar Products, to assist applicants in developing draft labeling for submission in applications for proposed biosimilar products. The recommendations for prescription drug labeling in the document pertain only to the package insert, except for recommendations that pertain to FDA-approved patient labeling such as patient information, Medication Guides, and instructions for use. It does not provide specific labeling recommendations for interchangeable biological products.

The guidance includes 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, instructions for submitting initial and revised labeling, and a discussion about interchangeable biological products.