Biosimilars and Interchangeable Biologics: Strategic Elements, 1st Edition (Paperback) book cover

Biosimilars and Interchangeable Biologics

Strategic Elements, 1st Edition

By Sarfaraz K. Niazi

CRC Press

599 pages | 13 Color Illus. | 16 B/W Illus.

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Description

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.

Table of 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

About the Author

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.

Subject Categories

BISAC Subject Codes/Headings:
MED009000
MEDICAL / Biotechnology
MED071000
MEDICAL / Pharmacology
SCI010000
SCIENCE / Biotechnology