World Market for Biosimilars and the Potential for US Follow-on Biologics

Biosimilars, or generic biologic drugs, are marketed around the world but still restricted in the U.S. This may soon change as Congress reviews pending legislation. Kalorama Information has released this timely study analyzing the market in Europe and other areas in the world, as well as the possibility of a U.S. Market in the near future.

This study is designed to provide a comprehensive look at the various strategies being used by select worldwide generic companies in exploring the emerging area of biosimilars, the issues and trends that are shaping the marketplace, and the potential feasibility of providing biogenerics within the United States regulatory environment.

As part of its coverage, this report provides the following key information:

Current market size and forecasts for biogenerics in Europe and Rest of World Markets
Review of Marketed Biological Drugs with Expired Patents
Review of Marketed Biological Drugs with Active Patents
Profiles of the Major Competitors in Biogenerics
Discussion of FDA and EMEA regulatory activity
Pending U.S. Legislation and Projections for US Markets
Coverage of Patent Trends, Pricing Trends, Healthcare Spending, IP and other Relevant Issues and Trends

For the purpose of this study, Kalorama has focused on the market for products which have lost their patent in key markets. Projections were made based on the progress that is occurring within the generics arena in terms of capabilities, capital, interest, and development of biopharmaceuticals.

Kalorama has identified the biopharmaceuticals that have lost patent protection and are likely to be the first products targeted by generic companies to attempt biosimilar development. Some of these products are relatively simple in structure (by biotech complexity) such as insulin and human growth hormone which represent a market of $40 billion, while others are extremely difficult to process.

Many of these products sport manufacturer sales of over $10 billion, presenting a ripe opportunity for generic manufacturers. At the same time, it is anticipated that there will considerable resistance from the biotech innovator companies in allowing generic capitalization and consequently approvals.

Our Methodology:

The information and analysis presented in this report are based on an extensive survey of senior management in the biogeneric drug industry. Background information was obtained from a comprehensive search of published literature and reports obtained from various government, business, medical trade, and international journals.

http://www.bioportfolio.com/cgi-bin/acatalog/The-World-Market-for-Biosimilars-and-the-Potential-for-US-Follow-on-Biologics.html

About Kalorama Information
Kalorama Information, a division of MarketResearch, supplies the latest in independent market research for the life sciences. To view their catalogue go to:

http://www.bioportfolio.com/cgi-bin/acatalog/Kalorama.html