Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan-Reference-Cited by-同舟云学术

Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan

Published:2024-07-02 Issue:7 Volume:24 Page:637-645
ISSN:1471-2598
Container-title:Expert Opinion on Biological Therapy
language:en
Short-container-title:Expert Opinion on Biological Therapy

Author:

Kuribayashi Ryosuke¹²,Goto Kanoko¹,Hariu Aya¹,Kishioka Yasuhiro¹

Affiliation:

1. Office of Cellular and Tissue-Based Products, Pharmaceuticals and Medical Devices Agency, Chiyoda-ku, Tokyo, Japan

2. Office of Regulatory Science Research, Pharmaceuticals and Medical Devices Agency, Chiyoda-ku, Tokyo, Japan

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/14712598.2024.2377300

Reference71 articles.

1. MHLW. Guideline for ensuring the quality safety and efficacy of biosimilars. 2020 [cited 2024 Mar 30]. Available from: https://www.pmda.go.jp/files/000267479.pdf

2. US FDA. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. 2015 [cited 2024 Jan 3]. Available from: https://www.fda.gov/media/82647/download

3. EMA. Guideline on similar biological medicinal products (CHMP/437/04 Rev 1). 2014 [cited 2024 Jan 3]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf

4. EMA. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: nonclinical and clinical issues. 2015 [cited 2024 Jan 3]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-and-clinical-issues-revision-1_en.pdf

5. MHLW. Questions and answers (Q&A) regarding the guideline for the quality safety and efficacy assurance of biosimilars. 2020 [cited 2024 Jan 3]. Available from: http://www.nihs.go.jp/dbcb/TEXT/Q&A_0204_1.pdf