More than two years ago, on January 17, 2017, the U.S. Food and Drug Administration released its Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This Guidance, entitled Nonproprietary Naming of Biological Products, extended to both reference biologic drug products and their biosimilar counterparts. The basis for this naming regime, and its extension to both types of biologic drugs, reflected the agency's rationale for providing a naming convention in the first place and was based on FDA's dual responsibilities to protect the public and at the same time facilitate availability of biosimilar drugs according to Congress's intentions in passing the BPCIA.
On March 8th, the FDA released its updated, revised, draft Guidance on non-proprietary naming of biological products, for comment purposes only. The draft Guidance announces the update in the Introductory Section, stating that nonproprietary names of products that did not have an FDA-designated suffix would no longer be required to be revised in order to accomplish the objectives of the naming convention described in the January 2017 Guidance. Similarly, the FDA does not intend to apply this naming convention (wherein the nonproprietary name is the combination of a core name, equivalent to a generic name for small molecule drugs combined with a four-letter suffix to designate its source but that was devoid of any meaning that would indicate its source, a so-called "nonsense" suffix). Further, the draft Guidance states that this naming convention would not be applied to any biologic drug approved under Section 202 of the Food, Drug, and Cosmetics Act as of March 23, 2020, the sunset date wherein such drugs will be considered to be approved under a biologics license application (BLA) under section 351 of the PHS Act (known as transition biologic products).
New in this draft Guidance is "FDA's current thinking" regarding the naming convention to be applied to interchangeable biosimilar products under Section 351(k) of the PSHA. Like biosimilar products under the earlier Guidance, the FDA intends to designate a proper name that is a combination of the "core name" and a distinguishable suffix equally devoid of meaning composed of four lowercase letters. While not decided the draft Guidance indicates that the FDA is considering whether to include vaccines within this naming convention.
As in the earlier Guidance, the FDA justifies this draft Guidance by stating the purported advantages: to facilitate pharmacovigilance, facilitate accurate identification of these products by source and/or manufacture, and help minimize (preferably, prevent) inadvertent substitution of biological products.
The first substantive section, entitled "Scope," sets forth the biological products falling within the scope of this draft Guidance as including "therapeutic protein products, vaccines, allergenic products, and blood derivatives, and do not include in vitro reagents (e.g., antibody to hepatitis B surface antigen, blood grouping reagents, hepatitis C virus encoded antigen), blood donor screening tests (e.g., HIV and hepatitis C), and those reagents used in determining donor/recipient compatibility in transfusion medicine. Section III provides background, including the earlier naming convention Guidance.
Section IV of the draft Guidance announces that the FDA will no longer impose a modification of previously licensed biological products to contain FDA-designated suffix because the Agency has determined that "the core objectives of the naming convention — pharmacovigilance and safe use — can be accomplished by applying the naming convention to biological products at the time they are licensed under section 351 of the PHS Act, and without applying it to licensed biological products that do not contain a suffix in their proper names." The change is intended to "minimize the potential burden upon sponsors and the healthcare system and avoid the possibility of confusion regarding previously approved biological products. The Guidance also espouses the FDA's belief that "applying the naming convention to all biological products at the time they are licensed under 351(a) or 351(k) is expected to mitigate the risk of inaccurate perceptions of the relative safety and effectiveness of biological products based on licensure pathway."
Turning to vaccines, the draft Guidance asserts that vaccines are within the scope of the current Guidance, and notes that it will determine whether currently available identification systems used for vaccine administration are sufficiently robust to provide "optimal pharmacovigilance" and safe dispensing practices without using distinguishable proper names.
Turning to interchangeable products, the draft Guidance states that the FDA considered two approaches: either providing a unique suffix that would distinguish the interchangeable product from other products having the same core name, or using a suffix shared with the reference product. The Agency has concluded that interchangeable products need their own unique suffix, to permit adequate pharmacovigilance (i.e., providing a means to track which biological product is dispensed to particular patients). Using a unique suffix will also avoid having to change those products first licensed as a biosimilar and later licensed as an interchangeable product. The draft Guidance imposes on the applicant for an interchangeable product the requirement to suggest "a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name designated by FDA at the time of licensure," for example during the investigational new drug (IND) phase or when a BLA is submitted. The FDA requires "up to 10 proposed suffixes," in Applicant preference order. In a supplement to an approved 351(k) application the draft Guidance directs that the applicant would keep the nonproprietary name of the biological product and the FDA-designated suffix and not submit further suffixes; this will be the name used throughout the propose labeling of the interchangeable product.
For the absence of doubt, the draft Guidance closes with a glossary of several of the terms used throughout the Guidance.
And like all such Guidances, this draft Guidance contains an express disclaimer:
The period for comments by the public extends until 60 days after the draft Guidance is published in the Federal Register, or until May 7, 2019. Comments should be directed to https://www.regulations.gov (if electronic) and written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The draft Guidance directs that all comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
Finally, questions regarding this draft Guidance should be directed to Sandra Benton, 301-796-1042, or (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010.
