March 6, 2015 BPC Statement on FDA Approval of Filgrastim Biosimilar

The Biologics Prescribers Collaborative (BPC) welcomes the U.S. Food and Drug Administration (FDA)’s decision today to approve the first biosimilar in the United States, Sandoz’s biosimilar to Amgen’s Neupogen™ (filgrastim). This approval represents an important step towards realizing the promise of biosimilars to expand patient access to these lifesaving therapies.

BPC appreciates FDA’s continuing deliberation on the biosimilars naming issue and the Agency’s careful decision not to rush ahead with a guidance document. Patient safety must be prioritized to ensure the safe use of biosimilars, and BPC believes that this pharmacovigilence is best achieved through the use of unique non-proprietary names for all biologics. For this approval, FDA has provided a placeholder nonproprietary name for the product as “filgrastim-sndz.” FDA has stated that the provision of a placeholder non-proprietary name for this product should not be viewed as indicative of the Agency’s decision on a comprehensive naming policy for biologics. While FDA has not yet issued draft guidance on how current and future biological products marketed in the U.S. should be named, BPC urges them to do so in the near future.

While the approval of Sandoz’s filgrastim-sndz represents the first approval of a biosimilar, FDA has recognized that it is not the best example on which to rest a decision on biosimilars naming. Filgrastim is a simple molecule that FDA has described as relatively small and easy to characterize. It is not representative of the majority of biosimilars that are under development. In the coming weeks, FDA will evaluate the first monoclonal antibody biosimilar application. Because of the unique product attributes of these large, complex biosimilars, it is critical that unique identifiers are used to track and identify what biologic product has been dispensed.

As biosimilars continue to be evaluated by FDA, as well as official agency guidances issued, the BPC will continue to weigh in and to provide the critical perspective of biologics prescribers to ensure patient safety.

The Biologics Prescribers Collaborative is an organization of groups representing physicians who regularly prescribe biologics that aims to ensure that sound policies are in place to promote the safest possible use of all biologics, including biosimilars, for all patients.

For additional information, please contact BPC’s lead physician co-convener Dr. Dennis R. Cryer, M.D. at [email protected].

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