Biosimilars Forum Issues Statement on FDA Draft Industry Guidance on Labeling for Biosimilar Products

Washington, DC, March 31, 2016 – The Biosimilars Forum – the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States issued the following statement on draft industry guidance on Labeling for Biosimilar Products released today by the Food and Drug Administration (FDA).

The Biosimilars Forum appreciates the FDA issuing this draft guidance on Labeling. We are pleased that the FDA is continuing to provide guidance for this developing industry. We believe this is an important topic and the guidance will provide greater clarity.

The introduction of biosimilars in the U.S. can help expand access to high-quality treatment options for clinicians and patients as well as reduce costs to families, caregivers, payers, and the health care system.

The Forum will carefully review the guidance and will submit comments to the FDA within the 60 day comment period.

About the Biosimilars Forum

The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.

To learn more about biosimilars, the Forum, and how to get involved, visit or go to @USbiosimilars to follow related conversations and join the dialogue.

Aimee Steel

Lynn Blenkhorn