Forum Statement on Proposed FDA Guidance on Naming of Biological Products

WASHINGTON, DC, (August 27, 2015) – The Biosimilars Forum is pleased that the FDA has issued a proposed rule to designate official names and proper names for certain biological products as well as a draft guidance on Nonproprietary Naming of Biological Products. These are important steps in helping to clarify policy issues related to biosimilars.

We applaud the FDA for reinforcing within the proposed regulation the approach that each biosimilar is a unique drug. We believe this important distinction supports the Forum’s position on the CMS J Codes for biosimilars; as single source drugs, biosimilars require separate J Codes.

The Forum is concerned that the CMS proposed rule may limit the future treatment options that health care professionals would be able to offer their patients and thus thousands of patients who are expected to benefit from biosimilars may have limited access to these therapies.

The Forum is carefully reviewing the FDA proposed rule and draft guidance and will provide comments. It is of the utmost importance to the Forum that regulators create biosimilars policies that promote patient safety and quality, as well as the sustainability of this new 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

Lynn Blenkhorn