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Drop biologic suffixes IGBA urges US FDA

Additional identifiers such as suffixes to international non-proprietary names (INNs) are not needed for successful traceability and identification of biological drugs, the International Generic and Biosimilar Medicines Association (IGBA) argues in an updated position. “No data exists to demonstrate that added non-memorable suffixes in the US will improve the US pharmacovigilance system,” the international trade body has stressed ahead of a US Food and Drug Administration (FDA) public hearing on “facilitating price competition and innovation in the biological products marketplace” to be held on 4 September (Generics bulletin, 3 August 2018, page 9).

Additional identifiers such as suffixes to international non-proprietary names (INNs) are not needed for successful traceability and identification of biological drugs, the International Generic and Biosimilar Medicines Association (IGBA) argues in an updated position. “No data exists to demonstrate that added non-memorable suffixes in the US will improve the US pharmacovigilance system,” the international trade body has stressed ahead of a US Food and Drug Administration (FDA) public hearing on “facilitating price competition and innovation in the biological products marketplace” to be held on 4 September (Generics bulletin, 3 August 2018, page 9).

“Many currently licensed originator biologics in the US have shared non-proprietary names for decades with no pharmacovigilance concerns,” the IGBA...

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