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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

FDA Commissioner’s Rx For US Biosimilars Market: Reform Contracting Practices And Payment Models

In unveiling the agency’s Biosimilar Action Plan, FDA's Gottlieb continued his pattern of provocative remarks by criticizing brand company practices and payment models that impede biosimilar competition and could ultimately undermine innovation. He also called for more action by the Federal Trade Commission and downplayed the impact interchangeability could have on biosimilar uptake. 


Biosimilars Biologics

Interchangeability Won’t Solve US Biosimilar Market’s Woes, FDA’s Gottlieb Says

FDA's Biosimilar Action Plan aims to boost approvals, but Commissioner Gottlieb says he's had a change of heart about how much impact an interchangeability designation can have on market uptake.

Biologics Biosimilars

Biosimilar Labeling: US FDA’s Final Guidance Means Status Quo For Sponsors

Advice document, little changed from a March 2016 draft, continues to reflect agency’s view that clinical studies supporting a demonstration of biosimilarity should not be included in labeling.

Biosimilars Regulation

Biologics Transition Plan From US FDA Will Consider Therapeutic Equivalence Ratings

While industry awaits formal guidance ahead of March 2020 transition deadline for certain protein products, FDA's Christl says plan will take into account therapeutic equivalence ratings when deciding whether products are 'deemed' licensed as full biologic applications or biosimilars.

Biosimilars Biologics

Siga Ready For Next Phase, New Cash With Smallpox Drug Approval

Siga is entitled to a $41m “hold back” payment under its contract with the Biomedical Advanced Research and Development Authority and potentially a $50m payment related to the US FDA's extended shelf-life determination for stockpiled Tpoxx; company also picks up first priority review voucher awarded for a medical countermeasure, which it likely will monetize.


Approvals Animal Testing

GSK's Tafenoquine Faces Questions Over Review Pathways At US FDA Panel

Advisory committee questions about malaria drug’s breakthrough therapy and orphan drug designations reflect lingering confusion about how agency’s various regulatory pathways impact product development and approval.

Advisory Committees Drug Review
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