Introduction and geographic availability of new antibiotics approved between 1999 and 2014

Background Despite the urgent need for new, effective antibiotics, few antibiotics of value have entered the market during the past decades. Therefore, incentives have been developed to stimulate antibiotic R&D. For these incentives to be effective, geographic availability for recently approved antibiotics needs to be better understood. In this study, we analyze geographic availability and market introduction of antibiotics approved between 1999 and 2014. Material and method We identified antibiotics, considered new chemical entities (NCEs) for systemic use approved globally between 1999 and 2014, from national medicine agencies’ lists of approved drugs, and data from the WHO Collaborating Center for Drug Statistics. Geographic availability was mapped using sales data from IQVIA, and analyzed with regards to class, indication, safety, and origin. Results Of the 25 identified NCEs, only 12 had registered sales in more than 10 countries. NCEs with the widest geographic availability had registered sales in more than 70 countries within a ten-year timeframe and 30 countries within a three-year timeframe, spreading across five different geographic regions and three country income classes. Half (52%) of the NCEs had an indication for infections caused by antibiotic- resistant bacteria, little diversity was seen regarding target pathogen and indication. Antibiotics originated from and/or marketed by companies from the US or Europe had greater geographic availability compared to Japanese antibiotics, which seldom reached outside of Asia. For 20 NCEs developers chose to fully or partially sublicense marketing rights to a number of companies of different sizes. Conclusion Our findings show great variation in geographic availability of antibiotics, indicating that availability in multiple regions and country income classes is possible, but rarely seen within a few years of market authorization. Sublicensing agreements between multiple companies was common practice. Moreover, differences were seen between countries regarding benefit/risk evaluations and company behavior. These findings could be a potential source of uncertainties, and create barriers to assure that working antibiotics are developed and made available according to public health needs.

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PID https://www.doi.org/10.1371/journal.pone.0205166
PID pmc:PMC6191083
PID pmid:30325963
URL http://europepmc.org/articles/PMC6191083?pdf=render
URL https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6191083/
URL http://dx.plos.org/10.1371/journal.pone.0205166
URL https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0205166&type=printable
URL https://academic.microsoft.com/#/detail/2896418674
URL http://dx.doi.org/10.1371/journal.pone.0205166
URL https://brage.bibsys.no/xmlui/handle/11250/2570809
URL https://jhu.pure.elsevier.com/en/publications/introduction-and-geographic-availability-of-new-antibiotics-appro
URL http://hdl.handle.net/11250/2570809
URL https://dx.plos.org/10.1371/journal.pone.0205166
URL https://fhi.brage.unit.no/fhi-xmlui/handle/11250/2570809
URL https://doaj.org/toc/1932-6203
URL https://www.duo.uio.no/handle/10852/67984
URL http://hdl.handle.net/10852/67984
URL http://europepmc.org/articles/PMC6191083
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Access Right Open Access
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Author Hege Salvesen Blix, 0000-0002-4890-7555
Author Eili Klein, 0000-0002-1304-5289
Author Kevin Outterson, 0000-0003-2513-3216
Author Elena Martinez, 0000-0001-9800-6651
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Collected From Norwegian Institute of Public Health Open Repository; PubMed Central; ORCID; UnpayWall; Norwegian Open Research Archives; DOAJ-Articles; Crossref; Microsoft Academic Graph
Hosted By Europe PubMed Central; Norwegian Institute of Public Health Open Repository; PLoS ONE; Norwegian Open Research Archives
Publication Date 2018-01-01
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Country Norway
Format application/pdf
Language English
Resource Type Article
keyword Q
keyword R
keyword keywords.General Biochemistry, Genetics and Molecular Biology
system:type publication
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Source https://science-innovation-policy.openaire.eu/search/publication?articleId=dedup_wf_001::d171f7c7f1a7221eec65fda9cc9ed721
Author jsonws_user
Last Updated 26 December 2020, 19:38 (CET)
Created 26 December 2020, 19:38 (CET)