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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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Biosimilars Sponsors Seek Changes In US FDA Guidance On Comparative Analytical Assessments

Companies generally support decision not to require statistical equivalence testing but challenge agency’s skepticism about combining data from US and foreign reference products to set analytical similarity acceptance criteria.

Biosimilars Biologics

Gilead, US FDA Ponder Innovative Designs For Descovy HIV Prevention Study In Women

Advisory committee sent a clear message that pre-exposure prophylaxis studies are needed in cisgender women, but what those studies might look like, and whether the agency can exercise its statutory authorities to ensure they are conducted, is less clear.

Advisory Committees Clinical Trials

Gilead’s Marketing Of Descovy For HIV Prevention Should Not Suggest Superiority To Truvada

US FDA advisory committee members urge agency to hold a firm line against labeling, promotional or educational materials that suggest Descovy has better efficacy or is safer than Truvada, which will face generic competition in 2020. Panel backs HIV pre-exposure prophylaxis indication for Descovy but recommends excluding cisgender women due to lack of clinical efficacy data.

Advisory Committees Advertising, Marketing & Sales

Gilead's Descovy HIV Prevention Indication Should Exclude Women, US FDA Advisory Cmte. Says

Gilead and the FDA failed women by letting PrEP application get this far without clinical efficacy data in non-transgendered females, panel members say in close vote against a broad indication; panelists urge the agency to mandate such studies regardless of the breadth of the HIV pre-exposure prophylaxis indication ultimately granted to the Truvada successor.

Advisory Committees Drug Review

Gilead's Descovy May Have Problem Getting HIV Prevention Indication In Cisgender Women

Descovy demonstrated noninferiority to Truvada in men and transgender women who have sex with men, but pharmacokinetic data do not support a demonstration of pre-exposure prophylaxis efficacy in cisgender women, US FDA says in advisory committee briefing document.

Advisory Committees Drug Review

Biosimilars: Rise In US FDA Approvals Means Lower Or Flat User Fees In FY 2020

Fees for applications and approved products will stay the same, while product development levies will fall 36%, the FDA announces. The agency’s biosimilar activities are becoming more reliant on funding from the growing number of products approved and less on those still in development.

Biosimilars FDA
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