Quality, safety and efficacy of follow-on biologics in Japan-Reference-Cited by-同舟云学术

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Quality, safety and efficacy of follow-on biologics in Japan

Published:2011-09 Issue:5 Volume:39 Page:328-332
ISSN:1045-1056
Container-title:Biologicals
language:en
Short-container-title:Biologicals

Author:

Yamaguchi Teruhide,Arato Teruyo

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference12 articles.

1. WHO guidelines presage US biosimilars legislation?;Hodgson;Nat Biotech,2009

2. Toward biosimilar monoclonal antibodies;Schneider;Nat Biotech,2008

3. Concept paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies. EMEA/CHMP/BMWP/632613/2009.http://www.ema.europa.eu/pdfs/human/biosimilar/63261309en.pdf.

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3. Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022;BioDrugs;2023-05-25

4. Biosimilars in Oncology: Latest Trends and Regulatory Status;Pharmaceutics;2022-12-05

5. Challenges for Streamlining the Development of Biosimilars: A Japanese Perspective;Clinical Pharmacology & Therapeutics;2022-11-17

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