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Injectable biologic therapies for the treatment of secondary care indications will be the chief drivers of sales growth in the United States out to 2014, fueled by a high unmet need that is satisfied by these drugs combined with their high price points and recent entry into the market, according to Datamonitor’s recent “Pharmaceutical Key Trends 2010” report. Of new drug approvals by the U.S. Food and Drug Administration in 2009, 27 percent (7 out of 26) were biologic license applications, the highest proportion of biologic approvals since 2003. The number of orphan drug designations has more than doubled in the last decade, from 207 to 444, while the number of orphan drug approvals grew from 32 to 47, an increase of 47 percent. Monoclonal antibody therapies will lead the growth of biologic therapies. Bevacizumab (Avastin), trastu-zumab (Herceptin), rituximab (MabThera), adalimumab (Humira), and infliximab (Remicade), which held the lion’s share of mAB sales in 2008, will be given a run as more mABs are projected to enter the market.
All is not rosy, however. The growth of biologics will present reimbursement issues as payers are forced to make tough decisions regarding which drugs they will pay for among all the offerings available.
“The small molecule market has dried up, and specialty drugs are where the market is right now, probably for the next decade,” says Jeffrey Dunn, PharmD, formulary and contract manager at Select Health, in Utah. “And it will be a while before we see the impact of biosimilars.” What we need, says Dunn, are better systems to capture data. “There are technology issues, knowledge gaps, and benefit design issues that prohibit plans from proper management right now.”