The FDA has released its final guidelines on the naming of biologic products, titled “Nonproprietary Naming of Biological Products.”1 As per the naming convention recommended in the guidance, reference biologics and biosimilar drugs should be given a nonproprietary name that is a “combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.”1
The FDA asserts that this method of naming will enable pharmacovigilance in situations where other forms of dispensed drug–tracking are unavailable; support patients and healthcare providers in accurately distinguishing and identifying these drugs; aid in reducing the unintentional use of 1 drug to substitute another where interchangeability has not been determined; and potentially decrease erroneous perceptions of biologic safety and efficacy determined by the licensure pathway.
ACR’s Comments on Naming Guidance
In a recent press release, the American College of Rheumatology (ACR) commended the FDA’s guidance on this important topic.2
“The American College of Rheumatology has long advocated for explicit guidance about distinct names and suffixes for biosimilars in order to prevent inadvertent or inappropriate substitution, increase prescriber confidence and uptake of biosimilars, and ensure pharmacovigilence [sic]. This is a welcomed step toward ensuring that biosimilars reach our patients as safely, transparently and efficiently as possible,” said Angus B. Worthing, MD, FACP, FACR, Chair, Government Affairs Committee, ACR, Atlanta, GA, in the release.
According to the ACR, a practical benefit of the guidance is that in situations where a biosimilar is not considered interchangeable, a pharmacist must ask the prescribing physician for a new prescription before switching a patient to or from a reference biologic. Citing the FDA, the ACR press release also noted that the new naming convention will be more effective than the use of alternative identifiers (eg, brand names) for addressing concerns about pharmacovigilance.
“The ACR supports the FDA’s recommendation of distinct suffixes for both biosimilars and reference biologics, so as to prevent prescribers from perceiving that drugs with suffixes are less safe or effective. One of our top priorities is to ensure that more affordable treatments reach our patients as quickly as possible, so we applaud the FDA’s measured and thoughtful approach to addressing provider confidence concerns while also prioritizing the safety of our patients,” Dr Worthing said.
ACR’s Comments on Interchangeability Guidance
The FDA has also released a draft guidance titled “Considerations in Demonstrating Interchangeability With a Reference Product,” which outlines important factors that sponsors should take into account regarding biologics and biosimilars, including clinical trial design, use of container closure systems, and the data required to signify interchangeability.3 In another press release, the ACR said that it is in favor of the draft guidance’s ability to potentially address safety and efficacy concerns, and to lower drug costs.4
“This guidance brings us one step closer to the shared goal of lowering prices in the biologics marketplace. While the ACR is still reviewing the document...our initial reaction is that the draft guidance strikes a good balance between ensuring safety and efficacy while also getting biosimilar products to market as efficiently as possible,” said Dr Worthing in the press release. He also noted that the ACR approved of the FDA’s call for clinical trials that involve having patients switch back and forth from a drug instead of just from the reference biologic to the biosimilar.
“The use of at least 2 exposure periods to each drug will mimic to some extent what our patients are likely to experience with changing formularies in a multi-payer, multi-state, ever-changing market,” he said.
- US Food and Drug Administration. Nonproprietary naming of biological products: guidance for industry. January 2017. www.fda.gov/downloads/drugs/guidances/ucm459987.pdf. Accessed January 17, 2017.
- American College of Rheumatology. ACR applauds FDA guidance requiring distinct names and suffixes for biosimilars and reference biologics. January 13, 2017. www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/793/ACR-Applauds-FDA-Guidance-Requiring-Distinct-Names-and-Suffixes-for-Biosimilars-and-Reference-BiologicsPress%20Releases. Accessed January 17, 2017.
- US Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product. January 2017. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid ances/UCM537135.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed January 18, 2017.
- American College of Rheumatology. ACR statement on FDA biosimilar interchangeability draft guidance. January 18, 2017. www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/795/ACR-Statement-on-FDA-Biosimilar-Interchangeability-Draft-Guidance. Accessed January 18, 2017.