T-29: Implementing Distinguishable Suffixes for Biologics: Considerations for Application to Previously Licensed Products

Poster Presenter

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy
Eli Lilly and Company
United States

Objectives

To facilitate discussion on the implementation of recent changes to FDA naming guidance for biologics - including the addition of a four-letter suffix. In particular, retrospective implementation (to already marketed products) is examined, and the impact to the healthcare system described.

Method

We conducted an assessment of the internal and external landscape to identify and address the potential concerns with retrospective application of FDA suffixes. Here, we present the results of this assessment and outline an implementation plan to minimize the impact and costs to stakeholders.

Results

Retrospective implementation of the FDA suffix will have some impact to all stakeholders. We identified opportunities to minimize the impact and costs to the overall healthcare system while maintaining the goal of providing improved product identification and patient safety. In particular, potential implications to stakeholders such as compendia, EHR vendors, pharmacies, and hospital systems are examined. Financial implications to manufacturers were also considered. These studies provided enough information to detail a framework for retrospective implementation that will streamline the application of the FDA suffix while minimizing negative affects on stakeholders.

Conclusion

Four-letter suffix codes unique to a specific manufacturer have been proposed by both the US FDA and the WHO as a tool for product identification and pharmacovigilance for biologics. In efforts to support the introduction of biosimilars into the US market, the guidance calls for the application of a unique four-letter suffix to the non-proprietary name of biological products. FDA has stated that the use of the suffix is aimed at facilitating pharmacovigilance through accurate identification of products by healthcare professionals and by minimizing the likelihood of inadvertent substitution at the pharmacy level for products not deemed to be interchangeable. While prospective implementation of this guidance has already begun, application to already marketed products (i.e. retrospective application) is being viewed by some as more complex and burdensome. We conducted an assessment of the internal and external landscape to identify and help address the potential concerns with retrospective application of FDA suffixes. Here, we present the results of this assessment and outline an implementation plan designed to minimize the impact and costs to the overall healthcare system while maintaining the goal of providing improved product identification and patient safety.