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FDA Publishes Draft Guidance Regarding Biosimilars Labeling

04/05/16

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Steven Lucio, PharmD, Associate Vice President, Pharmacy Services

In December I blogged about the long, slow journey biosimilars are taking toward mainstream market adoption in our country. I am excited to now be able to blog about another important step forward!

On March 31, I received an email notification from the U.S. Food and Drug Administration (FDA) announcing the publishing of their long-awaited draft guidance, “Labeling for Biosimilar Products.”

The guidance document issued last Thursday reflects the FDA’s current thinking and its recommendations for biosimilar manufacturers regarding another essential aspect of biosimilar approval—naming and labeling. Specifically, the guidance identifies the circumstances throughout a biosimilar label when the proprietary name, proper name; i.e. nonproprietary name, including the proposed four-letter suffix, or the core name; i.e. shared name of biological component, should be used.

This topic has been the subject of much debate between the branded industry and manufacturers pursuing biosimilar development. What is important in the new draft guidance is the FDA states that given a determination that a biosimilar has no clinically meaningful differences with a reference product in terms of safety, purity and potency, the label of a biosimilar can reflect the safety and efficacy information of the reference product. According to the FDA, the clinical data supporting a biosimilar application are intended to validate biosimilarity to the reference product, but are not necessarily designed to demonstrate safety and efficacy independently.

The guidance states that clinical data from biosimilarity studies may not be relevant to a practitioner’s consideration of safety and efficacy and may even result “in an inaccurate understanding of the risk-benefit profile of the product.” The label will include the year in which the biosimilar was initially approved and a biosimilarity statement articulating its relationship to the originator reference product.

The publication of this document represents another meaningful step toward a fully characterized biosimilar approval and marketing pathway.

This draft guidance also highlights the FDA’s efforts to balance the perspectives of both the branded and biosimilar industry.

Branded manufacturers are likely to disagree with the decision to have the label focus primarily on the clinical and efficacy information of their originator products. Conversely, biosimilar manufacturers may find the inclusion of the biosimilarity statement in the product label as less than desirable. I expect there to be a high volume of feedback from manufacturers on both sides as well as from trade organizations and individuals wanting to insure an appropriate level of pharmacovigilance. Additional details regarding the opportunity to provide feedback on this draft guidance is available in the April 4 edition of the Federal Register.

About the author. In his role at Vizient, Lucio guides member organizations in their efforts with various clinical practice topics, including improving medication safety, mitigating the impact of drug shortages, benchmarking pharmacy costs for key drug classes, evaluating the expense of high-cost biologics and preparing for the future development of biosimilars. A subject matter expert in the field of biosimilars, Lucio is lead author of a recently published peer-reviewed article on the topic, he is an active speaker and panel moderator and has presented his insight on biosimilars more than a dozen times in the past year.

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