This new edition explores the strategic planning side of biosimilar drugs and targets the issues surrounding biosimilars that are linked to legal matters. This includes an examination of new regulatory requirements in terms of principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. Biosimilars and Interchangeable Biologics: Strategic Elements, Second edition, examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. The book presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle. Updated throughout, the book covers strategic planning elements that include an overall understanding of the history and the current status of the science and art of biosimilars. As the perception of biosimilars has changed over the last several years, the author provides detailed descriptions of the new legal, regulatory, and commercial characteristics that must be considered. He also addresses the utilization of biosimilars and related biological drugs in expanding world markets, and reviews new strategies and tactics to enable users to create a universal dossier. Finally, there is also an examination of newer technologies that will help reduce the capital costs of manufacturing and bringing biosimilars to market. The book is intended for pharmaceutical scientists, engineers in biotechnology, regulatory specialists, analytical chemists, and quality assurance specialists in biopharmaceuticals.
