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Sumimasa Nagai

University of Tokyo

36

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284

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The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions.

2021 Oncologist
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Current situation of oncology biosimilars in Japan.

2021 Lancet Oncology
- Sumimasa Nagai
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Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan.

2019 International Journal of Molecular Sciences
- Sumimasa Nagai
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Biosimilar Filgrastim Use in the United States vs the European Union and Japan—Why Does It Lag Behind and What Can Be Done?

2019 JAMA Oncology
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Generic drugs in oncology – Authors' reply

2017 Lancet Oncology
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New Japanese Regulatory Frameworks for Clinical Research and Marketing Authorization of Gene Therapy and Cellular Therapy Products

2017 Current Gene Therapy
- Sumimasa Nagai
- Keiya Ozawa
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Evolving Japanese regulations on companion diagnostics

2016 Nature Biotechnology
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Clinical trial designs to obtain marketing authorization of drugs for haematological malignancy in Japan, the EU and the US.

2016 British Journal of Haematology
- Sumimasa Nagai
- Keiya Ozawa
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Regulatory approval pathways for anticancer drugs in Japan, the EU and the US

2016 International Journal of Hematology
- Sumimasa Nagai
- Keiya Ozawa
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Analysis of Drugs for Hematological Malignancy That Were Granted Accelerated Approval and Feasibility of Randomized Phase 3 Clinical Trials for Relapsed and Refractory Hematological Malignancy

2016 Blood
- Sumimasa Nagai
- Keiya Ozawa
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