I. INTRODUCTION The field of biopharmaceutical and biotechnology drugs, broadly referred to as "biologics," has grown dramatically over the past thirty years to comprise a major sector within the prescription drug market. (1) Biologics are drugs generally derived from living materials, including blood-derived products, vaccines, and most protein products. (2) The biotechnology industry has now brought to market over 254 new medicines, (3) products that account for one out of every eight prescriptions written worldwide. (4) The global market for biologics reached $75 billion in 2007, (5) and biologics sales continue to expand dramatically in relation to those for traditional small-molecule drugs. (6) In 2000, biologics accounted for eleven percent of the top 100 best-selling drugs on the market. (7) By 2014, biologics will account for seven of the top ten best-selling drugs on the market and fifty of the top 100. (8)
