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Biosimilar and Interchangeable Biologics

From Cell Line to Commercial Launch, Two Volume Set

Sarfaraz K. Niazi (Therapeutic Proteins International, LLC, Chicago, Illinois, USA)

$630

Hardback

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Apple Academic Press Inc.
23 December 2015
What's the Deal with Biosimilars?

Biosimilars 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.

Biosimilars and Interchangeable Biologics: From Cell Line to Commercial Launch covers the strategic and tactical elements of biosimilars in two volumes.

The first volume, Biosimilars and Interchangeable Biologics: Strategic Elements, 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.

This 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.

The second volume, Biosimilars and Interchangeable Biologics: Tactical Elements, 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.

This 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.

Thus, Biosimilars and Interchangeable Biologics: From Cell Line to Commercial Launch, Two-Volume Set supplies practitioners, researchers, and scientists in the biopharmaceutical industry with a valuable resource for practical information at all stages of the biosimilar product process.
By:   Sarfaraz K. Niazi (Therapeutic Proteins International LLC Chicago Illinois USA)
Imprint:   Apple Academic Press Inc.
Country of Publication:   Canada
Dimensions:   Height: 279mm,  Width: 216mm, 
Weight:   4.332kg
ISBN:   9781482298918
ISBN 10:   1482298910
Pages:   1174
Publication Date:   23 December 2015
Audience:   General/trade ,  College/higher education ,  Professional and scholarly ,  ELT Advanced ,  Primary
Format:   Hardback
Publisher's Status:   Active
BIOSIMILARS AND INTERCHANGEABLE BIOLOGICS: STRATEGIC ELEMENTS 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 BIOSIMILARS AND INTERCHANGEABLE BIOLOGICS: TACTICAL ELEMENTS Structural and Functional Elements Basics Multidimensional View Primary Structure Secondary Structure Tertiary Structure Quaternary Structure Posttranslational Modification (PTM) Protein Folding Protein Structural Variability Recombinant DNA Bibliography Immunogenicity Considerations Introduction Immune System Antigens Antibody Protein Immunogenicity Biosimilar Product Immunogenicity Immunogenicity Testing Conclusion Bibliography Product Development Strategies Background Selection of Product Manufacturing System Selection Cell Line Choice Reference Product Test Method Development Specifications Reverse Engineering Analytical and Functional Similarity Nonclinical Studies Clinical Pharmacology Studies Interchangeability Protocols Regulatory Uncertainty Legal Teams in Place Commercialization Challenges Bibliography Stability and Formulation Considerations Introduction Formulation of Biosimilar Products Common Formulation Elements High Concentration Formulations Stability Testing Guidance Bibliography Biosimilarity Tetrahedron Tetrahedron Concept Similarity Concept Comparability versus Similarity Analytical and Functional Similarity Analytical Instrumentation Identity Purity Potency Safety Clinical Data Risk-Based Critical Quality Attributes Nonclinical Data Stages of Analytical Similarity Level of Similarity Statistical Modeling of Similarity Data Interchangeability Conclusion Bibliography Recombinant Expression Systems Background Expression System Development Manipulations to Improve Yield Mammalian Cells Expression Systems Mammalian Cell Expression Improvements Yeast Expression Systems Insect Cells Transgenic Animals Cell Banks Bibliography Upstream Systems Optimization Background Bacterial Manufacturing Systems Mammalian Manufacturing Systems Yeast Cell Manufacturing Systems Transgenic Animal Systems Cell Lines and Characterization Future Prospects Bibliography Downstream Systems Optimization Introduction Bacterial Downstream Processing Mammalian Downstream Yeast Downstream Processing Insect Cell Processing Transgenic Animals Processing Bibliography Single-Use Manufacturing Systems (SUMS) Background Safety of Single-Use Systems Polymers and Additives Regulatory Requirements Risk Assessment Single-Use Containers Summary Single-Use Mixing Systems Connectors and Transfers Filtration Controls Filling and Finishing Systems Environmental Concerns Bibliography Commercial Manufacturing Overview Introduction Media Culture Growth Process Overview Process Maturity Validation Scale-Up Specific Scale-Up Issues Specific Economy Issues Process Materials Environment Control Biosafety Levels Good Manufacturing Controls of Active Pharmaceutical Ingredients Cleaning Procedures Processing and Filling Laboratory Testing Laboratory Controls Documentation Bibliography Outsourcing Considerations Background Value of Outsourcing Factors to Consider in Outsourcing Key Requirements What to Outsource? Cell Line Suppliers CMOs Biopharmaceutical Support Services Analytical Support Providers Contract Research Organizations Product Development Services Fill and Finish Providers Legal Matters Managing Outsourcing Outlook

Sarfaraz K. Niazi, PhD, is the founding executive chairman of Therapeutic Proteins International LLC, a world-class pure-play developer and manufacturer of biosimilar and interchangeable recombinant biologics, headquartered in Chicago. Dr. Niazi began his career teaching pharmacy at the University of Illinois (1972-1988), where he became a tenured professor. He then entered the pharmaceutical industry at Abbott International, becoming a Volwiler Fellow. He left Abbott in 1995 with a passion for making high-cost biological drugs affordable. Dr. Niazi set up several ex-U.S. biosimilar companies and, in 2003, established Therapeutic Proteins International, the only U.S. integrated company of its kind to date.

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