With Injectable Biologic Therapies on the Rise, Payers Face Tough Reimbursement Issues

摘要

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. Beva-cizumab (Avastin), trastu-zumab (Herceptin), rituximab (MabThera), adalimumab (Humira), and infliximab (Remi-cade), 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.