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The Registration of Biosimilar Medicines: The Case of Low Molecular Weight Heparines in View of the New CHMP Guideline

Time

Mon, Jun 24 10:00AM
M 09

Title

The Registration of Biosimilar Medicines: The Case of Low Molecular Weight Heparines in View of the New CHMP Guideline

Abstract Summary

The study was conducted at the Medical University of Warsaw at the Department of Pharmacoecononomics as a part of master thesis in 2012. The main source of data to analyze was the set of EMA and FDA guidelines regarding biosimilars as well as Citizen Petition and FDA’s answer to it.

Poster Presenter

Anna Magdalena Perelka
Trainee,
European Medicines Agency
United Kingdom

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