70 stakeholder groups call on the FDA, urging distinguishable, meaningful suffixes for biosimilars

May 18, 2016 1:04 PM

In a letter to the FDA this week, a 70-group coalition of healthcare stakeholders including patient and provider organizations and others urged the use of distinguishable, meaningful suffixes for biosimilars.

The letter to Leah Christl, Ph.D., FDA’s associate director for therapeutic biologics, comes on the heels of FDA’s departure from a meaningful to random identifier in the agency’s approval of the second biosimilar.

“Biosimilars hold great promise for millions of individuals living with debilitating, life-altering diseases and we appreciate your ever-vigilant efforts to promote access to these treatments,” the signatories wrote. “We believe that by the FDA instituting a distinguishable naming system for biological medicines that incorporates meaningful, memorable suffixes we will achieve these goals by providing strong patient protections, critical transparency and promoting pharmacovigilance, resulting in greater prescriber confidence.”

“There is no margin of error for patients who are managing serious and complex conditions,” said Kathleen Arntsen, President and CEO of the Lupus and Allied Diseases Association who collaborated with the Alliance for Safe Biologic Medicines on the grassroots initiative by gathering signatures and sending a strong signal to the FDA. Arntsen added that “Precise prescribing and documentation of adverse events is absolutely a matter of life and death for individuals struggling to live with these diseases.”

“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.”

The letter notes strong support for the coalition’s position among both physicians and pharmacists. In a survey of 400 prescribers of biologic medicines and 401 U.S. pharmacists, 60 percent and 77 percent, respectively, indicated their preference for meaningful over random suffixes.

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