Access to new antibacterials in 10 Asian countries: An Asian network for surveillance of resistant pathogens study

Abstract

Objectives Although new molecular entity (NME) antibacterials active against multidrug-resistant organisms have been introduced, their availability remains limited even in developed countries. This study aimed to examine the current availability of NME antibacterial agents in Asia. Methods NME antibacterials approved by the US FDA from 2010 to 2024 were included. Approval status in ten Asian countries was collected as of June 2025. Population and economic status were sourced from the United Nations and World Bank databases. Investigators reported approval, withdrawal, and unit prices of study drugs as well as the type of healthcare systems using a standardised report form. Results Among 22 NME antimicrobials included in this study, thirteen were approved in the surveyed countries. Beta-lactam/beta-lactamase inhibitors such as ceftazidime/avibactam and ceftolozane/tazobactam were the most approved class, each available in nine and eight countries, respectively. Agents active against carbapenem-resistant Acinetobacter spp. were available in three countries: cefiderocol (Japan, Singapore, Taiwan) and eravacycline (Singapore). The median number of available NME antibacterials per country was 3.5, ranging from one to six. For most NME antibacterials, a delay of three to five years existed between US FDA approval and approval in study countries. The number of available NME antibacterials showed no significant correlation with gross domestic product, relative drug price, or healthcare delivery system, except for approval lag. Conclusions Access to NME antibacterials in Asia remains markedly limited, with substantial approval delays. Considering the severity of antimicrobial resistance in the region, concerted efforts are warranted to improve access to crucial antibiotics in Asia.