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Biosimilars: Global Markets
Date:6/26/2012

NEW YORK, June 26, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

 

Biosimilars: Global Markets

http://www.reportlinker.com/p0919318/Biosimilars-Global-Markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Generic_Drug

 

REPORT SCOPE

 

INTRODUCTION

 

Biosimilars are comparable versions of original biopharmaceuticals. Since biologics are highly complex molecules, it is not possible to make identical copies of them. Hence, these products are not technically biogenerics. The differences of the biosimilar products from the reference biologic drug can be attributed to various manufacturing details including differences in expression systems, cell cultures, and many other bioprocessing conditions in the process.

 

Since it is scientifically impossible to make identical copies of biologic drugs, biologic drugs often enjoy an extended market exclusivity period. However, the need to deal with rising healthcare costs has made it necessary to develop regulatory guidelines to analyze and approve copies of biologic drugs. The European Medicines Agency (EMA) has been the pioneer and the leading regulatory agency to establish guidelines for the approval of biosimilars. Several other regulatory agencies including the World Health Organization (WHO) have followed the EMA guidelines to a great extent in establishing their own guidelines.

 

The recent expiry of data protection or patents for the first group of biopharmaceuticals has opened up the possibility of developing biological products similar to these original products and to rely for licensing in part on the extensive knowledge gained with the originator products. Although c
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