Biosimilarity The FDA Perspective

Sarfaraz K. Niazi

ISBN : 9781498750394
Publisher : Taylor and Francis Books Limited U.K.
Publication Year : 2018
Imprint : CRC Press
CD Included : No
Pages : 398
Binding : Hardback

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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. The FDA is quite different from other regulatory agencies. With the US providing more than 50% of the worldwide market for these products, every serious manufacturer of biosimilar biological drugs should be targeting US approval of their products. Thus, this book is strictly on FDA approval strategy.

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