Biosimilars and Interchangeable Biologics

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

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• Farmacologia
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