All Camps Agree: Memorable Biosimilar Names are a Must

December 9, 2015

The U.S. Food and Drug Administration has received comments from more than 170 groups on its proposal for naming biosimilars. Biosimilar makers, insurers and pharmacies largely oppose distinct nonproprietary names (also known as proper names) for biosimilars. By contrast, innovators (including those that develop biosimilars), health care providers and patient advocacy groups view them as critical to ensuring patient safety. However, most stakeholders in both camps urged the FDA to use meaningful suffixes to distinguish biosimilars from originator products rather than suffixes “devoid of meaning.” The FDA proposed to add meaningless suffixes to the nonproprietary names of originator products to address concerns of biosimilar makers that distinguishable names will discourage adoption of biosimilar products. But biosimilar makers expressed concern that such meaningless suffixes will lead to a variety of errors and ultimately endanger public safety. The FDA may now revisit its proposal given the largely uniform preference of innovators and biosimilar makers alike for meaningful and memorable nonproprietary names, such as those that identify the manufacturer of the biologic.

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