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.

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.

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.

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.

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.

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.