Approvals of Protein Therapeutics Increasing Based on Advances in Biotech R&D

The advances made in biotechnology R&D during the late 1980s and 1990s have significantly boosted the chances of biological therapeutics coming to market today, according to a drug development study.

Of the more than 250 protein therapeutics now under development, roughly 50 will eventually be approved by the FDA, says a report released by the Tufts Center for the Study of Drug Development (CSDD).

Of these 50 protein therapeutics, 33 will be recombinant protein (rDNA) treatments and 16 will be monoclonal antibody (mAb) therapeutics, the CSDD said. Much of the clinical pipeline through 2008 focuses on oncology, immunological and cardiovascular/hemostasis product development, according to the study.

The biotech sector, however, faces some challenges. The rDNA market may confront strong competition from small-molecule drugs, particularly in oncology, immunological disorders and infectious diseases, said CSDD. Meanwhile, the emergence of biogenerics in Europe and Asia could increase price pressure and drive down profit margins for existing products, the study says.

For more information on the CSDD report, go to http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=52 (http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=52).