Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary-Reference-Cited by-同舟云学术

Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary

Published:2022-12-02 Issue:5 Volume:113 Page:1030-1035
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Florian Jeffry¹,Sun Qin²,Schrieber Sarah J.³,White Richard⁴,Shubow Sophie²,Johnson‐Williams Bernadette E.²,Sheikhy Morasa¹^ORCID,Harrison Nicholas R.⁵^ORCID,Parker Valerie J.⁵,Wang Yow‐Ming²^ORCID,Strauss David G.¹^ORCID

Affiliation:

1. Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. Office of Clinical Pharmacology Immediate Office, Office of Translational Sciences, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

3. Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

4. Booz Allen Hamilton McLean Virginia USA

5. Duke‐Margolis Center for Health Policy Duke University Durham North Carolina USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2795

Reference25 articles.

1. US Food and Drug Administration.Biosimilars action plan: balancing innovation and competition (2018). Accessed May 1 2022.

2. US Food and Drug Administration.Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product (2015). Accessed May 1 2022.

3. US Food and Drug Administration.Guidance for industry: clinical pharmacology data to support a demonstration of biosimilarity to a reference product (2016). Accessed May 1 2022.

4. Assessment of Availability, Clinical Testing, and US Food and Drug Administration Review of Biosimilar Biologic Products

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