Mondaq (12/02/15) Royzman, Irena; Siegel, Jacob F.

Dozens of groups have submitted comments to the Food and Drug Administration (FDA) in response to the agency's proposal for naming biosimilars. Biosimilar makers, insurers, and pharmacies tend to oppose distinct nonproprietary names, or "proper names" for biosimilars. In contrast, innovators, health providers, and patient advocates tend to think such names are important for patient safety. Both sides, however, are calling for FDA to use meaningful suffixes that distinguish biosimilars from originator products, instead of using suffixes that have no apparent meaning. Because of this general preference, FDA may reconsider its proposal. As it stands now, FDA has proposed using nonproprietary names that consist of the core nonproprietary name of the originator product with a distinct four-letter suffix for originator products and biosimilars. The proposed suffixes would have no meaning and could be difficult to remember. Amgen has written that "the suffix should be meaningful (by identifying the sponsor) and consistent across the product sponsor's portfolio." Others have expressed concern about public safety, such as adverse events that cannot be properly attributed.

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