Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop Summary-Reference-Cited by-同舟云学术

Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop Summary

Published:2022-11-04 Issue:1 Volume:113 Page:37-49
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Shubow Sophie¹,Sun Qin¹,Nguyen Phan Ai Len²,Hammell Dana C.²,Kane Maureen²,Lyman Gary H.³⁴,Gibofsky Allan⁵,Lichtenstein Gary R.⁶,Bloomgarden Zachary⁷,Cross Raymond K.⁸,Yim Sarah⁹,Polli James E.²^ORCID,Wang Yow‐Ming¹^ORCID

Affiliation:

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

2. School of Pharmacy University of Maryland Baltimore Maryland USA

3. Department of Medicine University of Washington Seattle Washington USA

4. Division of Public Health Sciences Fred Hutchinson Cancer Center Seattle Washington USA

5. Division of Rheumatology Weill Cornell College of Medicine New York New York USA

6. University of Pennsylvania School of Medicine Philadelphia Pennsylvania USA

7. Division of Endocrinology, Diabetes and Bone Disease, Department of Medicine Icahn School of Medicine at Mount Sinai Hospital New York New York USA

8. Division of Gastroenterology and Hepatology, Department Medicine University of Maryland School of Medicine Baltimore Maryland USA

9. Office of Therapeutic Biologics and Biosimilars, Office of New Drugs 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.2765

Reference80 articles.

1. Patient Protection and Afforable Care Act Pub. L No. 111–147 Section 7002 Approved Pathway for Biological Biosimilar Products(2010). Accessed May 13 2022.

2. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) & Center for Biologics Evaluation and Research (CBER).Considerations in demonstrating interchangeability with a reference product guidance for industry(2019).

3. U.S. Department of Health and Human Services Food and Drug Administration & Center for Drug Evaluation and Research (CDER).Clinical immunogenicity considerations for biosimilar and interchangeable insulin products guidance for industry(November 2019). Accessed May 21 2022.

4. Biosimilar Multidisciplinary Evaluation and Review (BMER) 351(k) BLA 761202 SB11 a proposed biosimilar to US‐licensed Lucentis. Accessed May 20 2022.

5. Purple Book Database of Licensed Biological Products(updated May 6 2022). Accessed May 20 2022.

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