Nav: Home

ACR applauds FDA guidance requiring distinct names and suffixes for biosimilars

January 13, 2017

WASHINGTON, DC (Jan. 13, 2017) - The American College of Rheumatology (ACR) today 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."
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. For more information, visit

American College of Rheumatology

Related Drugs Articles:

Using drugs for different diseases than initially intended for
Thousands of drugs have the potential to be effective against other diseases than they were developed for.
Virtual development of real drugs
systemsDock is a new, free on-line resource that makes screening for drugs faster and more accurate.
Migraine drugs underused
New research shows that more migraines could be safely treated with drugs that are known to constrict blood vessels.
Why cancer drugs can't take the pressure
A major reason why cancer drugs fail is that they cannot penetrate the high-pressure environment of solid tumors.
Designing better drugs
A new strategy for engineering protein fusions -- to make specific cell-targeted drugs without side effects -- could enable a safer, more potent class of protein drugs.
More Drugs News and Drugs Current Events

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Erasing The Stigma
Many of us either cope with mental illness or know someone who does. But we still have a hard time talking about it. This hour, TED speakers explore ways to push past — and even erase — the stigma. Guests include musician and comedian Jordan Raskopoulos, neuroscientist and psychiatrist Thomas Insel, psychiatrist Dixon Chibanda, anxiety and depression researcher Olivia Remes, and entrepreneur Sangu Delle.
Now Playing: Science for the People

#537 Science Journalism, Hold the Hype
Everyone's seen a piece of science getting over-exaggerated in the media. Most people would be quick to blame journalists and big media for getting in wrong. In many cases, you'd be right. But there's other sources of hype in science journalism. and one of them can be found in the humble, and little-known press release. We're talking with Chris Chambers about doing science about science journalism, and where the hype creeps in. Related links: The association between exaggeration in health related science news and academic press releases: retrospective observational study Claims of causality in health news: a randomised trial This...