{"product_id":"biosimilar-and-interchangeable-biologics-from-cell-line-to-commercial-launch-two-volume-set-9781482298918","title":"Biosimilar and Interchangeable Biologics: From Cell Line to Commercial Launch, Two Volume Set","description":"\u003cp\u003e • Author(s): Sarfaraz K. Niazi\u003cbr\u003e • Publisher: Taylor \u0026amp; Francis\u003cbr\u003e • Publisher Imprint: CRC Press\u003cbr\u003e • BISAC: Pharmacology\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003e\u003cem\u003eWhat's the Deal with Biosimilars?\u003c\/em\u003e\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003eBiosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eBiosimilars and Interchangeable Biologics: From Cell Line to Commercial Launch \u003c\/strong\u003ecovers the strategic and tactical elements of biosimilars in two volumes.\u003c\/p\u003e\u003cp\u003eThe first volume, \u003cem\u003eBiosimilars and Interchangeable Biologics: Strategic Elements\u003c\/em\u003e, explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets.\u003c\/p\u003e\u003cp\u003eThis volume also examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.\u003c\/p\u003e\u003cp\u003eThe second volume, \u003cem\u003eBiosimilars and Interchangeable Biologics: Tactical Elements\u003c\/em\u003e, explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products.\u003c\/p\u003e\u003cp\u003eThis volume also provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.\u003c\/p\u003e\u003cp\u003eThus, \u003cstrong\u003eBiosimilars and Interchangeable Biologics: From Cell Line to Commercial Launch, Two-Volume Set\u003c\/strong\u003e supplies practitioners, researchers, and scientists in the biopharmaceutical industry with a valuable resource for practical information at all stages of the biosimilar product process.\u003c\/p\u003e","brand":"Taylor \u0026 Francis","offers":[{"title":"Hardcover","offer_id":45237350760599,"sku":"9781482298918","price":38183.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9781482298918.webp?v=1769216284","url":"https:\/\/atlanticbooks.com\/products\/biosimilar-and-interchangeable-biologics-from-cell-line-to-commercial-launch-two-volume-set-9781482298918","provider":"Atlantic Books","version":"1.0","type":"link"}