A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies-Reference-Cited by-同舟云学术

A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies

Published:2022-12-22 Issue:1 Volume:113 Page:108-123
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Guillen Elena¹²,Ekman Niklas³,Barry Sean⁴,Weise Martina⁵,Wolff‐Holz Elena⁶

Affiliation:

1. Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Bellaterra, Spain

2. Clinical Pharmacology Service, University Hospital Vall d’Hebron, Barcelona, Spain

3. Finnish Medicines Agency Fimea Helsinki Finland

4. Health Products Regulatory Authority Dublin Ireland

5. Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Bonn Germany

6. Paul‐Ehrlich‐Institut PEI Str 51‐58 Langen Germany

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2785

Reference58 articles.

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2. The ‘totality-of-the-evidence’ approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product

5. Regulation of biosimilar medicines and current perspectives on interchangeability and policy

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