ACR Applauds FDA Guidance Requiring Distinct Names And Suffixes For Biosimilars And Reference Biologics

The American College of Rheumatology (ACR) recently applauded final guidance from the Food and Drug Administration recommending distinct suffixes for biosimilars and reference biologics, which rheumatologists say will be critical to ensuring patient safety and prescriber confidence in the era of biosimilars.

“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,” said Dr. Angus Worthing, MD, FACP, chair of the ACR’s Government Affairs Committee. “This is a welcomed step toward ensuring that biosimilars reach our patients as safely, transparently and efficiently as possible.”

The FDA guidance, “Nonproprietary Naming of Biological Products”, recommends that previously approved, originator drugs also have distinguishable suffixes and notes that distinguishing suffixes should help minimize inadvertent substitution of any products that have not yet been determined to be interchangeable.

One of the practical implications of the naming guidance is that a pharmacist must ask the prescribing doctor for a new prescription before switching the patient from a reference biologic, or vice versa, if the biosimilar is not deemed to be interchangeable.

The FDA also notes in the guidance that pharmacovigilance will be bolstered by this naming system because the “use of alternative identifiers, including distinct proprietary names or NDC numbers, is insufficient to address concerns regarding pharmacovigilance."

Finally, the FDA notes that using suffixes for both reference biologics and biosimilars will reduce the inaccurate perceptions of safety and efficacy of biological products based on licensure pathway.

Of note, the FDA did not provide guidance regarding future use of suffixes in interchangeable products.

“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,” said Dr. Worthing. “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.”

About The American College of Rheumatology (ACR)

The American College of Rheumatology (ACR) is the nation’s leading advocacy organization for the rheumatology care community, representing more than 6,400 U.S. rheumatologists and rheumatology health professionals. As an ethically driven, professional membership organization committed to improving healthcare for Americans living with rheumatic diseases, the ACR advocates for high-quality, high-value policies and reforms that will ensure safe, effective, affordable and accessible rheumatology care.