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:

• World
• US
• non-US

As part of overall market coverage of biogenerics, this report includes:

• Complete Overview
• 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
• Company Profiles

The following critical trends occuring in biogenerics are discussed:

• Worldwide Regulatory and Legislative Issues
• Asia and Biogenerics
• Scientific Issues
• Patent Issues
• Pricing Issues
• Barriers to Entry
• Innovator Strategies and Challenges
• Bulk Suppliers and Contract Manufacturing
• Bioequivalence Issues
• International Issues
• Low Cost Branded HGH
• Biogenerics and Health-Care Spending
• Intellectual Property

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.

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