Drug Discontinuation in Studies Including a Switch From an Originator to a Biosimilar Monoclonal Antibody: A Systematic Literature Review

Author:

Bakalos GeorgiosORCID,Zintzaras Elias

Funder

Roche

Publisher

Elsevier BV

Subject

Pharmacology (medical),Pharmacology

Reference46 articles.

1. Transitioning from first- to second-generation biosimilars: an appraisal of regulatory and post-marketing challenges;Blandizzi;Pharmacol Res,2018

2. Biosimilars: key regulatory considerations and similarity assessment tools;Kirchhoff;Biotechnol Bioeng,2017

3. Guideline on Similar Biological Medicinal Products;EMA,2014

4. Guidance on Scientific Considerations for Demonstrating Biosimilarity to a Reference Product;FDA,2015

5. Guideline on Evaluation of Similar Biotherapeutic Products (SBPs);WHO Expert Committee on Biological Standardization,2009

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