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BPC Statement on FDA Approval of Infliximab Biosimilar

April 6, 2016

The Biologics Prescribers Collaborative (BPC) welcomes the U.S. Food and Drug Administration (FDA)'s decision on April 5, 2016 to approve the second biosimilar in the United States, Celltrion's biosimilar to Janssen Biotech, Inc.'s Remicade(tm) (infliximab). 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 careful deliberation on biosimilar-related issues, however the decision to use a four letter randomized suffix in the naming of the biosimilar has raised many concerns. Patient safety must be prioritized to ensure the safe use of biosimilars, and BPC believes that pharmacovigilence is best achieved through the use of memorable and distinguishable non-proprietary names for all biologics. For this approval, FDA has provided a nonproprietary name for the product as "infliximab-dyyb."  In October of 2015, FDA released the "Nonproprietary Naming for Biologic Products" draft guidance, calling for each biological product to be a assigned a distinguishable name through the use of a four letter randomized suffix. However, a randomized four-letter code may complicate the achievement of FDA's goal to improve pharmacovigilance and prevent inadvertent substitution. A memorable suffix, such as one that reflects the manufacturer, is immediately recognizable and will facilitate prompt, accurate adverse event reporting by patients and physicians to the correct manufacturer, and that manufacturer's mandated reporting to FDA.

The approval of Celltrion's infliximab-dyyb represents the second approval of a biosimilar, yet the agency has not finalized their decision on a comprehensive naming policy for biologics. As such, the BPC strongly encourages FDA to adopt a suffix format that is memorable and reflective of the manufacturer name - as originally illustrated by filgrastim-sndz.

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