Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary.
Clin Pharmacol Ther
; 113(5): 1030-1035, 2023 05.
Article
em En
| MEDLINE
| ID: mdl-36380593
ABSTRACT
The US Food and Drug Administration (FDA) Biosimilars Guidance describes how biosimilars may be approved based on clinical pharmacokinetic and pharmacodynamic (PD) biomarker data, without comparative clinical studies with efficacy end points. This type of clinical development program, however, has only been implemented for a small number of FDA-approved biosimilar products over the last decade. To encourage the use of PD biomarkers in biosimilar development and approval, the Duke-Margolis Center for Health Policy collaborated with the FDA to host a two-day virtual public workshop entitled "Pharmacodynamic Biomarkers for Biosimilar Development and Approval" on September 20-21, 2021. The public workshop was a forum for global regulators, biopharmaceutical developers, and academic researchers to discuss the current and future role of PD biomarkers in improving the efficiency of biosimilar development and approval. The workshop objectives included (i) discuss the current and potential future state of leveraging PD biomarkers for biosimilar development and approval; (ii) summarize the FDA's initiatives to advance biosimilar development; (iii) describe stakeholders' experience with PD biomarkers in biosimilar development; and (iv) explain research efforts to promote broader application of PD biomarkers in biosimilar development. This document summarizes presentations and panel discussions from each session of the two-day September 2021 public workshop covering the application of PD biomarkers for biosimilar development.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Aprovação de Drogas
/
Medicamentos Biossimilares
Tipo de estudo:
Guideline
Limite:
Humans
País como assunto:
America do norte
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article