The US Food and Drug Administration (FDA) has issued draft guidance for the naming of biosimilars. The FDA proposal calls for attachment of 4-letter suffixes to distinguish a biosimilar from the originator product and biosimilars from other biosimilars.
The suffixes would be 4 random letters with the intent of preventing medical errors caused by inadvertent substitution of biologic agents that have not been determined to be interchangeable. According to the FDA, “there is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable.”
Manufacturers of branded biotech drugs have emphasized risks of switching patients from branded products to alternate versions, noting that biosimilars are not exact copies of the original molecule.
In a statement, the American College of Rheumatology (ACR) applauded the FDA draft guidance.1 “The ACR commends the FDA’s proposal to require distinctive names for biosimilar drugs and original biologics,” said Doug White, MD, chair of the ACR’s Committee on Rheumatologic Care. “Distinctive names will allow for greater transparency in substitution and notification, making it clear to all parties involved—pharmacists, providers, and patients—which drug the patient is receiving.”
The Biologics Prescribers Collaborative (BPC), an organization of groups representing physicians who regularly prescribe biologics, notes that distinguishable names are imperative to promote safety and enhance confidence in biologics because no 2 biologic products can be the same. “As biosimilars come to market, it is crucial for physicians to recognize that while highly similar, there will be differences between a biosimilar and the originator product as well as among all biosimilars of the originator,” BPC said in a statement.2
- American College of Rheumatology applauds FDA draft guidance requiring distinct naming for biosimilars [press release]. Atlanta, GA: American College of Rheumatology; August 28, 2015. http://www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/675/American-College-of-Rheumatology-Applauds-FDA-Draft-Guidance-Requiring-Distinct-Naming-for-Biosimilars. Accessed September 14, 2015.
- BPC statement on FDA draft guidance entitled “Nonproprietary Naming of Biological Products.” Biologics Prescribers Collaborative website. http://biologicsprescribers.org/resources/bpc-statement-on-fda-draft-guidance-entitled-nonproprietary-naming. Published August 27, 2015. Accessed September 14, 2015.