Biosimilars and interchangeable biologics. Strategic elements / (2016)

• Record Type: Book
• Other Titles: Strategic elements
• Further Information: Note: Sarfaraz K. Niazi.
• Authors: Niazi, Sarfaraz, 1949-
• Contents: Introduction to Biosimilar and Interchangeable Products; Background; Manufacturing Systems; Characterization Systems; European Perspective on Interchangeability; Legality of Interchangeability; Interchangeability Practices; The Naming Controversy; Label; Regulatory Approvals; EMA Status; Regulatory Filing Under 505(b)(2); eCTD Filing Requirements; Analytical Similarity; FDA Views on Development of Biosimilars; Nonclinical Testing; Immunogenicity; Phase III Trials; Pharmacovigilance; Commercial Opportunities; Epilogue; Bibliography; ; Intellectual Property Issues for Biosimilars; Global Patenting Perspective; Biological Patents; Patent Linkage; Purple Book; Patent Term Extension; Patent Term Adjustment; Determination of Target Launch Dates for Biologics; Loss of Patent Exclusivity; Freedom-to-Operate Opinions; Filing the 351(k) Triggers the Patent Dance; First Patent Dance Failed; Notice of Commercial Marketing and Preliminary Injunction; Sources of Uncertainty; Interchangeability; Bibliography; ; European Regulatory Guidance; Background; Publication of Clinical Data; 2014 Update; Product-Specific Guidance; Clinical Safety; Conclusion; Bibliography; ; EMA-Approved Biosimilars; Background; Somatropin (Omnitrope); Hyaluronidase; Enoxaparin; Filgrastim; Somatropin; Erythropoietin; Follitropin Alfa; Infliximab; Conclusion; Bibliography; ; FDA Regulatory Guidance; Background; Historical Perspective; Nonclinical Studies for Biologics; Biologics License Application; Guidance for Biosimilars; Biosimilarity; Clinical Pharmacology Data to Support Biosimilarity; Purple Book; Conclusion; Bibliography; ; ROW Regulatory Guidance; Background; Argentina; Australia; Brazil; Canadian Guidelines on Subsequent Entry Biologics (SEBs); Singapore; China; India; Islamic Republic of Iran (National Regulatory Authority); Japan; Jordan Food and Drug Administration; Mexico; Russia; South Korea; Turkey; United States of America; World Health Organization (WHO); Bibliography; ; US Commercialization; Background; Competition; Evolving Pharma Market; Industry Overview; Commercializing a Biosimilar; Industry Events and Forums; Print Materials; Advertising; Social Media; Website; Bibliography; ; Global Commercialization; Background; Product Naming Issues; Bibliography; ; Quality and Lifecycle Management; Background; Pharmaceutical Development; Critical Quality Attributes; Product Life Cycle Management and Continual Improvement; Quality Risk Management and Product and Process Development; Differing Approaches to Pharmaceutical Development; CMC Considerations for the Drug Substance; CMC Considerations for the Drug Product; Life Cycle Management; FDA Comparability Protocol (CP); CP Compilation Summary; Applicability of a CP; Components of a CP Submission; Reporting of the Manufacturing Change(s) Implemented Using an Approved CP; Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (Q5e); Operational Systems; Quality Control Systems; Bibliography; Appendices;
• Edition: 1st
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2016
• Extent: 1 online resource, illustrations (black and white, and colour)
• Subjects: 615.1; Pharmaceutical biotechnology; Pharmaceutical biotechnology industry; Recombinant proteins
• Languages: English
• ISBNs: 9781498743488
• Related ISBNs: 9781498743471
• Notes: Note: Includes bibliographical references and index.; Note: Description based on CIP data; item not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.