On August 28, 2015, FDA issued a draft guidance regarding nonproprietary naming of biological products, which addresses the agency's current thinking on the need for biological products to bear a nonproprietary name that includes an FDA-designated suffix. Additionally, FDA states that it believes that shared nonproprietary names are not appropriate for all biological products, finding a need for clearly identifiable products to support pharmacovigilance activities and to safely use products that have not been determined to be interchangeable. In releasing the draft guidance document, FDA put forth a series of questions in the notice relating to the benefits and challenges of using a suffix and related topics, requesting feedback by October 27, 2015. In a separate but related action, FDA issued a proposed rule to designate official names and proper names for certain biological products, including: (i) the reference products for an approved or publicly disclosed biosimilar application; (ii) a related biological product to one of the reference products; or (iii) biosimilar product. FDA is accepting comments on the proposed rule and its application by November 12, 2015.
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