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    Biosimilar naming method questioned

    FDA’s method for naming biosimilars and interchangeable biologics came under fire long before the first biosimilar, Zarxio, was approved last spring.

    Some physicians and pharmacists worry that using a nonproprietary proper name that includes a base active ingredient name plus a randomly-assigned four-letter suffix, such as the newly approved etanercept-szzs (Erelzi), will lead to prescribing errors and confusion.

    “We have advocated for a prefix on biosimilar names because, when you look at a screen, and you have a drug name that is 10 to 12 characters long, [prescribers and pharmacists] may just see the beginning of the name and not the suffix,” said Robert T. Adamson, PharmD, chief pharmacy officer, corporate pharmacy, for Barnabas Health in West Orange, N.J.

    However, the four-character suffixes are meant to improve safety, according to FDA, which is asking the industry for input on its draft guidance, Nonproprietary Naming for Biologic Products.

    “The goal of this naming convention is to help minimize inadvertent substitution. Inadvertent substitution may lead to unintended alternating or switching of biological products that have not been determined by FDA to be interchangeable,” FDA said in the draft guidance document. “This naming convention may also facilitate pharmacovigilance for multiple biological products containing related drug substances when other means to track a specific dispensed product are not readily accessible.”

    According to a recent survey, most pharmacists prefer FDA’s method of biosimilar naming with a nonproprietary proper name plus a suffix.  In fact, 48% of 781 members of the Academy of Managed Care Pharmacy and the Hematology/Oncology Pharmacy Association surveyed prefer this method, according to the study published in the Journal of Managed Care & Specialty Pharmacy.

    Christine Blank
    Contributing Editor Christine Blank is a freelance writer based in Florida.


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