Biosimilars and interchangeable biologics : strategic elements /
Sarfaraz K. Niazi
- xlv, 599 pages : illustrations ; 29 cm.
Includes bibliographical references and index.
Introduction to biosimilar and interchangeable products -- Intellectual property issues -- The EMA regulatory guidance -- EMA approved biosimilars -- The FDA regulatory guidance -- The ROW regulatory guidance -- US commercialization -- Global commercialization -- Quality and lifecycle management.
9781498743471 (hardcover : alk. paper)
2015031036
Biosimilar Pharmaceuticals--standards. Drug Approval. Drug Discovery--standards. Drug Evaluation--standards. Drug Industry--standards.