What’s in a Name? FDA Proposes Updates to Its Biosimilar Naming Policy

The US Food and Drug Administration (FDA) issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update (Guidance).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 FDA’s second attempt at guidance concerning nonproprietary name suffixes for biologic products. It also highlights the perceived tension between FDA’s pharmacovigilance role and goal of increasing the availability of biosimilars. At least for this round, FDA’s interest in tracking pharmacovigilance data seems to have received priority.

Through the updated Guidance, FDA announced four key changes to its approach to biologic product nonproprietary name suffixes.

• First, FDA stated that it will not modify the nonproprietary names of biologics that have already been licensed without a designated suffix. FDA Commissioner Dr. Scott Gottlieb stated in a press release accompanying the Guidance (Press Release) 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. In view of these potential issues, FDA determined that the agency’s pharmacovigilance goals could be accomplished without extending the new naming convention to already licensed products.
• Second, along the same vein, FDA will not apply the new naming convention to transition biologics. These products are biologics, such as 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. 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 non-interchangeable biosimilars, which will comprise a combination of a core name and a distinguishing suffix.
• Fourth and finally, FDA is reconsidering whether vaccines, which are currently within the scope of FDA’s biologic naming framework, should require suffixes, as currently available identification systems may meet FDA’s pharmacovigilance goals.

According to Commissioner Gottlieb, the approach outlined in the Guidance “will provide consistency among biologics and will help ensure health care 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 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, 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 non-interchangeable biosimilar products. This is not yet an immediate issue, because FDA has not licensed any interchangeable biosimilars. However, this issue will likely come to a head as more and more biosimilars are developed.

Ultimately, 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. FDA will receive public comment on this updated Guidance until May 7, 2019. Following the closing of the comment period, 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.

Contacts

If you have any questions or would like more information on the issues discussed in this LawFlash, please contact the authors, Christopher J. Betti, Ph.D. (Chicago), Jacqueline R. Berman (Washington, DC), or any of the following lawyers from Morgan Lewis’s IP Life Sciences Practice:

Boston
Stephen L. Altieri, Ph.D.
Mark L. Hayman, Ph.D.

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Olga Berson, Ph.D.

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Michael J. Abernathy
Jeffrey R. Gargano
Wan-Shon Lo
Sanjay K. Murthy
Kevin P. Shortsle
Krista Vink Venegas, Ph.D.
Amanda S. Williamson

Orange County
M. Todd Hales
Nathan S. Smith

Philadelphia
Louis W. Beardell, Jr.
Christopher I. Halliday
Eric Kraeutler

San Francisco
Brett A. Lovejoy, Ph.D.

Singapore
Jeffry S. Mann, Ph.D.*

Washington, DC
Janice H. Logan, Ph.D.
Gregory T. Lowen, Ph.D.
Robert Smyth, Ph.D.

_{*A solicitor of Morgan Lewis Stamford LLC, a Singapore law corporation affiliated ‎with Morgan, Lewis & Bockius LLP}