Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?

Author:

Tu Chien-Lung,Wang Yi-Lin,Hu Teh-Min,Hsu Li-Feng

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Reference48 articles.

1. Yu B. Greater potential cost savings with biosimilar use. Am J Manag Care. 2016;22(5):378.

2. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Rand Health Q. 2018;7(4):3.

3. Grewal S, Ramsey S, Balu S, Carlson JJ. Cost-savings for biosimilars in the United States: a theoretical framework and budget impact case study application using filgrastim. Expert Rev Pharmacoecon Outcomes Res. 2018;18(4):447–54. https://doi.org/10.1080/14737167.2018.1476142 .

4. Kurki P. Potential changes to the FDA approach to biosimilars have a global impact. GaBI J. 2018;7(2):53–8.

5. EMA. Guideline on similar biological medicinal products. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf . Accessed 16 Feb 2019.

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