In one sense, the opportunity for follow-on proteins is as good as ever. Some of the biggest-selling biologics developed during the first phase of the biotechnology revolution in the 1980s, including human growth hormone (hGH) and insulin, have lost patent protection or are set to lose patent protection in the US in 2007 and beyond. But there are also regulatory challenges to marketing follow-on biologics in the U.S. that companies will need to navigate to prosper.
In this report, Biogenerics: The World Market for Biosimilars Kalorama has identified key biologic products that are off patent and are either facing development of a generic competitor or are likely in Kalorama's estimate to face biogeneric competition in the future.
Since Kalorama Information last visited the market for synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies four years ago, there has been much more worldwide involvement in the development of the biogeneric arena.
Kalorama Information's survey includes as part of its market analysis a breakdown of generic replacements for:
Drugs with Active patents
Drugs with Expired patents
with this geographic breakdown:
As part of overall market coverage of biogenerics, this report includes:
Market Size Projections for Biogenerics Products
Patent dates for Major Biopharmaceuticals
Issues and Trends in the Industry
Scientific Differences Between Biopharmaceuticals and Biogenerics
Key Regulations Affecting this Market
The following critical trends occuring in biogenerics are discussed:
Worldwide Regulatory and Legislative Issues
Asia and Biogenerics
Barriers to Entry
Innovator Strategies and Challenges
Bulk Suppliers and Contract Manufacturing
Low Cost Branded HGH
Biogenerics and Health-Care Spending
As part of Kalorama Information's trusted information gathering process, this report is the result of both primary and secondary research. In addition to exhaustive research, Key executives at biogeneric companies were consulted to uncover key trends and develop models.
TABLE OF CONTENTS
CHAPTER ONE: EXECUTIVE SUMMARY
Scope and Methodology
Size and Growth of the Market
Trends Affecting the Market
CHAPTER TWO: INTRODUCTION AND OVERVIEW
Biopharmaceutical Industry and Approval Process
Regulations for Biopharmaceuticals
History of the Prescription Generic Pharmaceuticals Industry
History of the Generic Approval Process
Regulation of Prescription Generic Pharmaceuticals
Areas of Treatment for Biopharmaceuticals
CHAPTER THREE: BIOGENERIC PHARMACEUTICALS FOR EXPIRED BIOLOGIC PATENTS
Market Size and Growth
CHAPTER FOUR: BIOGENERIC PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS
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