1st Edition

Biosimilars and Interchangeable Biologics Strategic Elements

By Sarfaraz K. Niazi Copyright 2016
    646 Pages 13 Color & 16 B/W Illustrations
    by CRC Press

    646 Pages 13 Color & 16 B/W Illustrations
    by CRC Press

    646 Pages 13 Color & 16 B/W Illustrations
    by CRC Press

    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.

    Part of a two-volume set that covers varying aspects of biosimilars, 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.

    Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume 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 also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

    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

    Biography

    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.