Article

Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America

2016-11-01

Abstract excerpt

Developing countries have an estimate of ten times more approved biosimilars than developed countries. This disparity demands the need of an objective regulation that incorporates health policies according to the technological and economical capabilities of each country. One of the challenges lies on the establishment of comparability principles based on a physicochemical and biological characterization that shoul...

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Literature Corpus work: 75862df4-4661-52a5-9666-92df2c33dd43
DOI: 10.1016/j.ejbt.2016.10.003

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