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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

Reliance On ‘Digitized Paper’ Is Slowing Drug Development – US FDA’s Woodcock

Efficient development and review is being hindered by the inability to exchange data freely and truly capitalize on the digital age, CDER director says, challenging industry, regulators and others to creatively think about how to move away from legacy, paper-based processes in clinical trials and regulatory submissions.

Clinical Trials Drug Review

US FDA Drug Development Tool Qualification Takes Center Stage At December Meeting

Public session to gather input on taxonomy and scientific criteria for qualifying animal models, biomarkers and clinical outcome assessments is early step toward satisfying 21st Century Cures Act requirements and PDUFA VI commitments.

Research & Development Animal Testing

Expanded Access: US FDA Told To Increase Regulatory Clarity, Early Interactions With Sponsors

Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.

Research & Development Clinical Trials

Fulphila Clinical Development Timeline

Chronicle of the development and US FDA review of Mylan’s pegfilgrastim-jmdb (MYL-1401H), a biosimilar to Amgen’s Neulasta.

Drug Review Profile Biosimilars

Mylan’s Fulphila: First Neulasta Biosimilar’s Road To US Market Slowed Only By Product Quality, GMP Deficiencies

Mylan demonstrated analytical similarity, including for the PEG moiety, and the absence of clinically meaningful differences between MYL-1401H and Amgen’s pegfilgrastim during first review cycle, but it had to resubmit the application after FDA flagged concerns about the biosimilar’s manufacturing process and ongoing facility deficiencies.

Drug Review Profile Biosimilars

Fulphila Reviewers

FDA staff who participated in the review of Mylan’s pegfilrastim-jmdb, the first US-licensed biosimilar to Amgen’s Neulasta.

Drug Review Profile Biosimilars
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