Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – ( <scp>III</scp> ) A Randomized Trial with Interferon Beta‐1a Products-Reference-Cited by-同舟云学术

Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – ( III ) A Randomized Trial with Interferon Beta‐1a Products

Published:2022-12-02 Issue:2 Volume:113 Page:339-348
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Florian Jeffry¹,Gershuny Victoria¹,Sun Qin²,Schrieber Sarah J.³,Matta Murali K.¹^ORCID,Hazel Anthony¹^ORCID,Sheikhy Morasa¹^ORCID,Weaver James L.¹,Hyland Paula L.¹,Hsiao Cheng‐Hui¹,Vegesna Giri¹,DePalma Ryan¹,Shah Aanchal¹⁴,Prentice Kristin¹⁴,Sanabria Carlos⁵,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. Therapeutic Biologics Program, Office of Clinical Pharmacology, 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. Spaulding Clinical Research West Bend Wisconsin USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2784

Reference41 articles.

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

2. 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.

3. Pharmacodynamic biomarkers for biosimilar development and approval: workshop background (2021). Accessed May 1 2022.

4. Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

5. G-CSF and GM-CSF in Neutropenia

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