Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis.

ABSTRACT:

Background

Most cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new cancer drugs may influence regulatory decisions in other settings. The study examined whether characteristics of available evidence at FDA approval influenced time-to-marketing authorisation (MA) in Brazil, and price differences between the two countries.

Methods

All new FDA-approved cancer drugs from 2010 to 2019 were matched to drugs with MA and prices approved in Brazil by December 2020. Characteristics of main studies, availability of randomised controlled trials (RCTs), overall survival (OS) benefit, added therapeutic benefit, and prices were compared.

Findings

Fifty-six FDA-approved cancer drugs with matching indications received a MA at the Brazilian H

SUBMITTER: Ivama-Brummell AM 

PROVIDER: S-EPMC10206192 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature