Biosimilars and interchangeable biologics : strategic elements /
Niazi, Sarfaraz, 1949- ,
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.
RS 380 .N53 2016 / 2024-7072
QV 241
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.
RS 380 .N53 2016 / 2024-7072
QV 241