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Sue Sutter

Senior Editor

Washington, D.C.
Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.  She has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the umbrella of Informa Business Information, including Pink Sheet, “The Pink Sheet” DAILY, “The Tan Sheet” and Scrip.  Previously she worked as an editor for Mealey’s Litigation Reports (now part of Lexis-Nexis), writing about asbestos, toxic tort and fen-phen litigation.
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Latest From Sue Sutter

Abuse-Deterrent Opioids: US FDA Follows The ‘Route Of Abuse’ To Exclusivity

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.

Policy Approvals

Pediatric Drug Development A Priority For US FDA’s New Oncology Center Of Excellence

Existing regulatory authorities could be optimized to speed development of promising pediatric cancer therapeutics, particularly those that don’t work in adult cancers.

Regulation Pediatrics

Sandoz Tested Erelzi’s Suffix On Multiple Fronts

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 Biosimilars

How To Name A Biosimilar: Amgen Persisted With Amjevita Suffix Despite FDA Doubts

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.

Drug Review Profile Biosimilars

Amjevita Clinical Development Timeline

Chronicle of the development and FDA review of Amgen’s biosimilar adalimumab-atto (ABP 501).

Drug Review Profile Biosimilars

Amjevita Reviewers

FDA staff who participated in the review of Amgen’s adalimumab-atto, a biosimilar to AbbVie’s Humira.

Drug Review Profile Biosimilars
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