FDA Biosimilar Naming Proposal Pits Providers, Patients Against Insurers, Pharmacies
Executive Summary
Suffix-based, distinguishable names cheered by physicians and patient advocacy groups as enhancing patient safety; payers and pharmacists object, saying plan adds unneeded complexity and will require expensive overhauls in databases and operating systems.
You may also be interested in...
FDA Biosimilars Acting Director Yim Is ‘Not A Great Fan’ Of Suffix-Based Naming Policy
Whether one accepts the view that concerns about active pharmacovigilance and the need to distinguish small molecules from biologics support the controversial nomenclature system is ‘a personal thing,’ Sarah Yim says.
US FDA Biosimilars Acting Director Yim ‘Not A Great Fan’ Of Suffix-Based Naming Policy
Whether one accepts the view that concerns about active pharmacovigilance and the need to distinguish small molecules from biologics support the controversial nomenclature system is ‘a personal thing,’ Sarah Yim says.
Policy Reversal: FDA Will No Longer Require Suffixes For Older Biologics
New US FDA draft guidance says that the agency will no longer change the proper names of originator biologics to include a four-letter suffix, although the agency will continue to attach suffixes to future approvals.