By Christopher Betti, Jacqueline Berman, and Jennifer Dienes, Morgan, Lewis & Bockius LLP
The U.S. FDA issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update (“guidance”). This update is the FDA’s second attempt at a policy for nonproprietary name suffixes for biologic products. It also highlights the perceived tension between the FDA’s pharmacovigilance role and its goal of increasing the availability of biosimilars. At least for this round, the FDA’s interest in tracking pharmacovigilance data seems to have received priority.
By way of background, beginning in 2010 and following the enactment of the Biologics Price Competition and Innovation Act, the agency requested public comment on a variety of topics related to the newly established biosimilar pathway, including naming conventions. This culminated in a 2017 guidance document that required the use of a distinguishing suffix — comprised of four lower-case letters — attached to the nonproprietary names of both the originator and biosimilar products. At the time, the proposed naming convention would not only be applied prospectively to newly licensed biosimilar and originator products, but also would be applied to biologics that were already on the market, necessitating name changes. In this 2017 guidance, the FDA did not address how or whether it would distinguish biosimilars that it designated as interchangeable with the reference product.
The FDA’s naming proposal generated robust public feedback, which, according to FDA Commissioner Scott Gottlieb, “raised important concerns on the part of industry.” As summarized by the FDA, the debate has largely focused on “whether a distinguishing suffix should be added to the proper (i.e., nonproprietary) names of biologics to help ensure strong pharmacovigilance” and whether “the addition of a distinguishing suffix could serve as a barrier to the use of biosimilar products and brisk competition.”
After evaluating the public comments, the FDA issued new 2019 draft guidance, taking into consideration concerns raised regarding the proposed naming convention. Through the updated guidance, the FDA announced four key changes to its approach to biologic product nonproprietary name suffixes.
First, the FDA stated that it will not modify the nonproprietary names of biologics that have already been licensed without a designated suffix. Commissioner Gottlieb stated in a press release accompanying the guidance that this particular change was in response to concerns from stakeholders that retroactive name changes would impose substantial costs on the healthcare system and could cause confusion in the market as nonproprietary names of drugs seldom change post approval. In view of these potential issues, the FDA determined that the agency’s pharmacovigilance goals could be accomplished without extending the new naming convention to already licensed products. The FDA further stated that, through the prospective application of the naming convention to all biological products at the time they are licensed, the agency aims “ to mitigate the risk of false perceptions from health care providers and patients that there’s a difference in relative safety and effectiveness of” originator and biosimilar products based on product names.
Second, along the same vein, the FDA will not apply the naming convention to transition biologics. These products are biologics, like insulin, that are currently approved under New Drug Applications (NDAs) rather than Biologic License Applications (BLAs). In March 2020, however, these existing NDAs will be converted to BLAs and may serve as originator products for biosimilars. According to the press release, this step is to minimize burden, ensure patient stability, and advance the development of biosimilar and interchangeable products.
Third, interchangeable biosimilars will have a designated proper name like that of noninterchangeable biosimilars, which will comprise a combination of a core name and a distinguishing suffix. According to the FDA, this will avoid the need for changes to the nonproprietary name of a biological product that is first licensed as a biosimilar and later determined to be an interchangeable biosimilar.
Fourth and finally, the FDA is considering whether vaccines, which are currently within the scope of the agency’s biologic naming framework, should require suffixes, as currently available identification systems may meet the FDA’s pharmacovigilance goals.
According to Commissioner Gottlieb, the approach outlined in the guidance “will provide consistency among biologics and will help ensure healthcare providers and patients have confidence in the safety and effectiveness of any biological product on the market.” Commissioner Gottlieb further stated that the “framework will help secure pharmacovigilance so that the FDA can effectively monitor all biological products in the post market – originators and biosimilars – and promote patient safety.” According to the FDA, unlike in the generic drug space, biosimilar suffixes are necessary because “biologics are generally complex and typically impossible to replicate in the way small-compound drugs can be, and even though biosimilars have no clinically meaningful differences from the reference product, these unique suffixes are a critical component of the FDA’s ability to track adverse events to a specific biological product and manufacturer.”
This is not likely to be the last we hear on this issue and, in fact, the FDA expects continued discussion. One significant issue that the guidance is still silent on concerns whether and how interchangeable biosimilar products will be distinguished from other noninterchangeable biosimilar products. This is not yet an immediate matter, because the FDA has not licensed any interchangeable biosimilars. However, this will likely come to a head as more and more biosimilars are developed.
Ultimately, the FDA’s final guidance will likely be an attempt to strike a balance between the position that suffixes will assist with pharmacovigilance and the position that suffixes may inhibit biosimilar use and competition. Exactly where the balance will be struck, however, is yet to be seen. The FDA will receive public comment on this updated guidance until May 7, 2019. Following the closing of the comment period, the FDA intends to issue a revised, final version of the 2017 Nonproprietary Naming of Biological Products guidance that amends the relevant sections as necessary to incorporate the received input.
About The Authors:
Christopher Betti, Ph.D., is a registered patent lawyer and partner at Morgan, Lewis & Bockius LLP. He concentrates his practice on biotechnology and pharmaceutical patent matters with an emphasis on patent litigation and product life-cycle management. He also devotes a significant portion of his practice to intellectual property portfolio management, patent preparation and prosecution, pre-litigation counseling, due diligence analysis associated with venture capital financing and public offerings, and opinions and strategic advice relating to complex patentability, patent validity, infringement, and freedom-to-operate issues.
Jacqueline R. Berman is an associate at Morgan, Lewis & Bockius LLP. She advises companies on FDA regulatory, compliance, and enforcement issues, as well as clinical trials and FDA-regulated product development programs.
Jennifer M. Dienes is an associate at Morgan, Lewis & Bockius LLP. She concentrates on patent prosecution and litigation. Building on her background in biochemistry and molecular biology, she focuses her practice on biotechnology and pharmaceutical patent matters, including patent preparation and prosecution, intellectual property portfolio management, patent validity and infringement opinions, freedom-to-operate opinions, and patent litigation.
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