70 groups pen letter to FDA on biosimilar naming

SILVER SPRING, Md. — A group of 70 healthcare stakeholders sent a letter to the Food and Drug Administration this week, urging the agency to use meaningful, distinguishable suffixes when naming biosimilars. According to the Alliance for Safe Biologic Medicines, the letter was spurred by the agency choosing a random suffix when it approved the second biosimilar earlier this year. 

 

In April, the FDA approved Inflectra (infliximab-dyyb), a biosimilar of Remicade (infliximab), in April. The chosen four-letter suffix was random in accordance with the FDA’s recent draft guidance on biosimilar naming. In comparison, the first approved biosimilar was Sandoz’s Zarxio and is named filgrastim-sndz to distinguish from Neupogen (filgrastim). 

 

"Meaningful suffixes are easier for patients, providers and pharmacists to both recognize and remember, thus facilitating accurate association between adverse events and specific products," signatories wrote. "A suffix based on the manufacturer name, as was used in the Zarxio approval where '-sndz" refers to 'Sandoz', also promotes manufacturer accountability."

 

Among the signatories was the Lupus and Allied Diseases Association, whose CEO and president Kathleen Arnsten said “There is no margin of error for patients who are managing serious and complex conditions. Precise prescribing and documentation of adverse events is absolutely a matter of life and death for individuals struggling to live with these diseases.”