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Journal of Biopharmaceutical Statistics Volume 24, 2014 - Issue 6: Issues in Biosimilar Drug Development
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Original Articles

Clinical Development and Trial Design of Biosimilar Products: A Japanese Perspective

Masayuki NagasakiBiostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
&
Yuki AndoBiostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, JapanCorrespondence[email protected]
Pages 1165-1172 | Received 27 Oct 2013, Accepted 04 May 2014, Published online: 31 Oct 2014

REFERENCES

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  • Food and Drug Administration. (2012). Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Draft Guidance). Rockville, MD: Food and Drug Administration.
  • International Conference on Harmonization. (2000). E10 Guideline: Choice of Control Group and Related Issues in Clinical Trials. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E10_Guideline.pdf (accessed August 30, 2013).
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  • Pharmaceuticals and Medical Devices Agency. (2013). Review Report of Filgrastim (Genetical Recombination) (Filgrastim Biosimilar 2) (in Japanese). Tokyo, Japan: Pharmaceuticals and Medical Devices Agency. http://www.info.pmda.go.jp/shinyaku/P201300017/530191000_22500AMX00855_A100_1.pdf (accessed August 30, 2013).

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