Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (I) A Randomized Trial with <scp>PCSK9</scp> Inhibitors-Reference-Cited by-同舟云学术

Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (I) A Randomized Trial with PCSK9 Inhibitors

Published:2022-11-15 Issue:1 Volume:113 Page:71-79
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Sheikhy Morasa¹^ORCID,Schrieber Sarah J.²,Sun Qin³,Gershuny Victoria¹,Matta Murali K.¹^ORCID,Bai Jane P.F.¹,Du Xiulian³,Vegesna Giri¹,Shah Aanchal¹⁴,Prentice Kristin¹⁴,Nalepinski Colleen⁵,Zineh Issam⁶,Wang Yow‐Ming³^ORCID,Strauss David G.¹^ORCID,Florian Jeffry¹

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

3. 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

4. Booz Allen Hamilton McLean Virginia USA

5. Spaulding Clinical Research West Bend Wisconsin USA

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

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2769

Reference24 articles.

1. The Patient Protection and Affordable Care Act Pub. L No.111‐148 Section 7002 Approved Pathway for Biological Biosimilar Products. (2010). 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.biosimilars action plan: balancing innovation and competition (2018). Accessed May 1 2022.

4. 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.

5. US Food and Drug Administration.Highlights of prescribing information: Repatha. Accessed May 1 2022.

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