This article is more than 5 years old. Information may no longer be current.
Physician groups support proposed FDA biosimilar naming convention, but also call for maker ID
Click Here to Manage Email Alerts
Eight physician groups from various specialties of biologics prescribers have applauded the naming convention for biosimilars proposed by the FDA as it relates to the use of separate names for biosimilars to an originator product from different manufacturers; but the groups are calling for a memorable suffix that represents the manufacturer, rather than a suffix without meaning as currently proposed.
The groups, Alliance for Patient Access; American Association of Clinical Endocrinologists; American College of Rheumatology; Association of Black Cardiologists Inc.; Biologics Prescribers Collaborative; Coalition of State Rheumatology Organizations; Endocrine Society; and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, urged FDA to make the change in a letter to Acting Commissioner Stephen Ostroff, MD, in response to the draft guidance, “Nonproprietary Naming of Biological Products: Guidance for Industry.”
“Our experience as biologics prescribers tells us that the suffix must be memorable, which cannot be easily accomplished when it is meaningless,” the groups wrote. “A randomized four-letter code may complicate the achievement of FDA’s goal to improve pharmacovigilance and prevent inadvertent substitution. A memorable suffix could identify the manufacturer, which would be easily memorized by those who frequently prescribe biologics.”
The group further suggested that a name based on the manufacturer would “facilitate prompt, accurate adverse event reporting by patients and physicians to the correct manufacturer, and that manufacturer’s mandated reporting to FDA.”
In March, FDA approved the first biologic in the United States, Zarxio (filgrastim-sndz; Sandoz), a biosimilar to Neupogen (filgrastim; Amgen). At that time, the suffix “sndz” was derived from Sandoz, the manufacturer of the biosimilar.
The coalition of prescriber groups argued in the letter that this convention meets the needs of “biologics prescribers in day-to-day human interactions with patients, pharmacists, and other health care professionals. It will promote accurate prescribing, facilitate effective pharmacovigilance, and help to ensure manufacturer accountability,” they wrote.
References:
www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm.