The US Food and Drug Administration (FDA) has released new guidance for industry on nonproprietary naming of biological products licensed under the Public Health Service (PHS) Act. The guidance describes FDA’s current thinking on the need for nonproprietary names that include a core name and an FDA-designated suffix. Such ‘proper names’, which are the nonproprietary names designated by FDA in the license for a biological product licensed under the PHS Act, will include a distinguishing suffix that is composed of 4 lowercase letters devoid of meaning attached to a core name with a hyphen. For example, replicamab-cznm and replicamab-hjxf represent proper names for two products sharing one core name (replicamab). The FDA intends to use the adopted name designated by the US Adopted Name (USAN) Council as the core name for the relevant biological when available. FDA’s current thinking is that proper names including the suffix are warranted for originator biological products, related biological products and biosimilar products to facilitate pharmacovigilance and accurate identification by health care practitioners and patients, and to help minimize inadvertent substitution of products not determined to be interchangeable. Prospective naming, retrospective naming and naming of biosimilar products are discussed in the guidance. For prospective naming and naming of biosimilar products, the applicants should propose a suffix; in the case of retrospective naming of licensed products, the biological license application holders may propose a suffix.
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