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Latest From Sue Sutter
Inspirion’s MorphaBond win suggests agency’s thinking on three-year exclusivity for abuse-deterrent formulations has ‘evolved’ from a formulation-specific approach to one based on route of abuse.
Existing regulatory authorities could be optimized to speed development of promising pediatric cancer therapeutics, particularly those that don’t work in adult cancers.
Evaluations of potential nonproprietary name suffixes for the US biosimilar to Amgen’s Enbrel included checks on Internet search engines and databases of abbreviations and proprietary names, as well as safety, trademark and phonetic analyses.
Drug Review Profile examines how Amgen persuaded US agency that its preferred distinguishable suffix choice for Amjevita, a biosimilar to AbbVie’s Humira, would not be confused with medical abbreviations or existing trademarks.
Chronicle of the development and FDA review of Amgen’s biosimilar adalimumab-atto (ABP 501).
FDA staff who participated in the review of Amgen’s adalimumab-atto, a biosimilar to AbbVie’s Humira.