1st Edition
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
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.
