According to a survey published last fall, there are 102 biotechnology drugs in late-stage development. Products in late-stage development are defined as those that have completed a phase 2 trial and have moved on to a phase 3 trial or have been submitted to the U.S. Food and Drug Administration for a new indication. Of the 102, 25 percent have received previous FDA approval for other indications; 18 percent have completed phase 3 trials for an unapproved application.
Which diseases are targeted? Biotech products in late-stage development target 36 disease categories; cancer, for which there are 30 drugs in late-stage development, is the most prevalent.
A patient or caregiver will not administer the majority of products that are in late-stage development, and patients will not pick these new products up at the local pharmacy. In fact, 90 percent of the 102 late-stage products are administered by injection or by infusion. Payers will want administration will take place in ambulatory care settings to the greatest extent possible.
SOURCE: NAGLE PC, LUGO TF, NICITA CA. DEFINING AND CHARACTERIZING THE LATE-STAGE BIOPHARMACEUTICAL PIPELINE. AM J MANAG CARE. 2003 Oct;9(6 SUPPL): S124–S135.