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The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products.

Produktbeschreibung
The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products.
Autorenporträt
Sarfaraz K. Niazi Ph.D, is Adjunct Professor at the faculty of University of Houston as well Chairman and President of Therapeutic Proteins Inc.