FDA issues draft guidance on labeling for biosimilar products

The Food and Drug Administration today issued draft labeling recommendations for proposed biosimilar products, which pertain to prescribing information and certain FDA-approved patient labeling. In the guidance, FDA recommends an approach to labeling that relies largely on the safety and effectiveness information from labeling for the biosimilar product’s corresponding reference product. Comments on the draft guidance will be accepted for 60 days after notice of the guidance is published in the Federal Register. Specific labeling recommendations for interchangeable biological products will be provided in future guidance, the agency said.