TY - BOOK AU - Niazi,Sarfaraz TI - Biosimilars and interchangeable biologics: strategic elements SN - 9781498743471 (hardcover : alk. paper) AV - RS 380 .N53 2016 2024-7072 U1 - PY - 2016/// CY - Boca Raton PB - CRC Press/Taylor & Francis Group KW - Biosimilar Pharmaceuticals KW - standards KW - Drug Approval KW - Drug Discovery KW - Drug Evaluation KW - Drug Industry N1 - 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 ER -