Biosimilarity: The FDA Perspective
Biosimilarity: The FDA Perspective
CRC Press | English | 2019| ISBN-10: 1498750397 | 436 pages | PDF | 18.06 MB
CRC Press | English | 2019| ISBN-10: 1498750397 | 436 pages | PDF | 18.06 MB
by Sarfaraz K. Niazi (Author)
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
About the Author
Sarfaraz K. Niazi Ph.D, is Adjunct Professor at the faculty of University of Houston as well Chairman and President of Therapeutic Proteins Inc