Approval of new biopharmaceuticals 1999–2006: Comparison of the US, EU and Japan situations

Tsuji, Kaori; Tsutani, Kiichiro

doi:10.1016/j.ejpb.2007.07.013

Cited by 28 publications

(15 citation statements)

References 8 publications

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“…One study showed that the delay between the approval of a new drug in the United States (US) versus approval of the same drug in Japan was approximately 2.5 years [3]. Another study reported that the mean time required for approval of new biologics was 3.7 months in the US, 7.5 months in the European Union (EU), and 52.6 months in Japan [4].…”

Section: Introductionmentioning

confidence: 98%

The notorious “drug lag” for oncology drugs in Japan

et al. 2011

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This study aimed to analyze the oncology "drug lag" (i.e., the delay in time required for the approval of oncology drugs) in Japan compared with that in the United States of America (US) or the European Union (EU) and to identify the factors associated with this lag. Using publicly available information, we collected data on 42 approvals of 30 oncology drugs in Japan, the US, and the EU that included dates of drug development initiation, submission, review, and approval. Lags in each step of the process were then examined and compared among the three regions. We found that median submission and approval lag times between Japan and the US were 20.0 and 29.9 months, respectively, while those between Japan and the EU were 14.9 and 21.3 months, respectively. The median review periods for Japan, the US, and the EU were 14.3, 6.0, and 13.2 months, respectively, and the median lag in initiation of oncology drug development between Japan and the US/EU was 38.9 months. The proportion of approvals for which Japanese Phase I registration trials started after corresponding approvals in the US were 39% compared with 47% for the EU. Multivariate analysis suggests that delays in the initiation of drug development and the extended length of the regulatory review period in Japan may contribute to the longer oncology drug lag observed in Japan compared with that of the US or EU.

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Section: Introductionmentioning

confidence: 98%

The notorious “drug lag” for oncology drugs in Japan

et al. 2011

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“…There has been a rapid increase in demand for the production of clinically approved biopharmaceuticals for the treatment of human diseases (Butler, 2005;Tsuji and Tsutani, 2008;Walsh, 2006). Most of these are complex glycoproteins produced from genetically engineered mammalian cells in culture (Abdullah et al, 2008).…”

Section: Introductionmentioning

confidence: 99%

High productivity of human recombinant beta-interferon from a low-temperature perfusion culture

Rodrı́guez

Spearman

Tharmalingam

et al. 2010

Journal of Biotechnology

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“…The drug lag, the difference in the timing of drug approval between countries, is of increasing concern in Japan. Previous studies have suggested potential causes, 1,2 and the Japanese government has implemented a series of actions to shorten the drug lag. To accelerate the launch of important drugs already approved in the West but not yet approved in Japan, the Ministry of Health, Labor, and Welfare (MHLW) established the Study Group on Unapproved Drugs in 2005, and the Council on Unapproved Drugs and Indications with Unmet Medical Needs in 2010 3,4 .…”

Section: What Is Known and Objectivementioning

confidence: 99%