Biosimilars Forum Statement Regarding FDA’s Final Guidance on Nonproprietary Naming of Biosimilar Products

WASHINGTON, January 12, 2017 – The Biosimilars Forum — the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States — today issued the following statement regarding the Food and Drug Administration’s (FDA) final guidance for industry on nonproprietary naming of biological products.

“The Biosimilars Forum appreciates the ongoing efforts of the FDA to provide guidance on outstanding biosimilar policy issues. While we are pleased that the FDA has finalized the guidance, we are disappointed in their decision to apply meaningless suffixes in the naming convention for biological drugs. Non-meaningful suffixes will certainly be more difficult for physicians and patients to recall than meaningful suffixes. Additionally, they will likely lessen the ability to carefully track the identity of the biologic drug administered to patients, thereby contrary to the stated purpose of having a suffix to enhance pharmacovigilance.

“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 systems. Biosimilars are a key free-market solution to lowering drug costs, and we will continue to work with the FDA to advance these products to the marketplace.

“We look forward to learning more about the FDA’s plans for renaming of biologics that are already approved, as well as for the naming convention that will be implemented for interchangeable biologics. We hope the FDA will continue to finalize other much needed guidances for industry.”

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 Lubin

Lynn Blenkhorn