While the development of an abbreviated regulatory pathway is crucial to the approval of new biogenerics, growing concerns about the lack of a definition for bioequivalence and increasing pressure from major biotechnology companies anxious to defend their ailing blockbuster patents are preventing this from happening. This is currently the single largest restraint facing the biogenerics market. Although the European Agency for the Evaluation of Medicinal Products (EMEA) is now accepting applications for abbreviated market approval of new biogenerics, the United States is yet to develop a shorter regulatory path to market. On the other hand, biogenerics are thriving in less regulated countries such as India and China.
This Frost & Sullivan research service provides an in-depth strategic analysis of the global biogenerics market along with an assessment of its immense potential. It discusses various critical issues such as regulatory affairs that could hinder the development of the market. The detailed pipeline analysis includes anticipated patent expiry dates for the most successful biopharmaceuticals and analysis of forthcoming biogeneric products expected to be launched from 2005 to 2011.
