FDA Releases Long-Awaited Biosimilars Naming Scheme

September 5, 2015

The Biologics Price Competition and Innovation Act (BPCIA), passed as part of the Affordable Care Act (ACA) in 2010, created a new pathway for the regulation and approval of biological products that are demonstrated to be “biosimilar” with an Food and Drug Administration (FDA)-licensed biological product. Although the legislation was signed into law more than five years ago, and the first U.S. biosimilar was approved in March (Sandoz’s filigrastim-sndz), stakeholders including biologics and biosimilars manufacturers, patients and clinicians have all been eagerly awaiting the Agency’s release of final guidance on the critical elements of FDA approval of biosimilars, including by what name biosimilars will be called, which conditions they may treat, and by what process they would be considered interchangeable with existing innovator biologics. Finally, late last month, the FDA released long-awaited documents outlining the agency’s current thinking on the naming of biosimilars.

First, FDA issued draft guidance, “Nonproprietary Naming of Biological Products,” proposing to use suffixes as part of nonproprietary names for biosimilars and reference biologics, noting that there is a clear need to identify biological innovator products as well as to differentiate among biological products that have not been determined to be interchangeable. In addition to the draft guidance on biosimilars naming, FDA also issued a proposed rule, “Designation of Official Names and Proper Names for Certain Biological Products,” that proposes to rename six currently licensed biologic products for which there are pending biosimilars applications, to align their official and proper names with the convention proposed in the draft guidance.

CLSA is pleased with FDA’s draft guidance and believes that this naming convention will help ensure appropriate use of biological products by helping to minimize inadvertent substitution and alternating of biological products that have not been determined by FDA to be interchangeable; enhancing pharmacovigilance by ensuring the ability to track adverse events to individual manufacturers; and advancing appropriate practices and perceptions regarding biological products.

For questions, please contact Jenny Carey, CLSA’s Director of Federal Government Relations and Alliance Development (