By Helena R. Berger
Florida Sun Sentinel
January 4, 2012
A number of medical breakthroughs have helped individuals with severe and chronic disabilities. Many of these are biotech medicines, or biologics, which are advanced prescription drugs made from living organisms rather than chemicals. Biologics are used to treat serious disabilities like Multiple Sclerosis, Parkinson’s and Rheumatoid Arthritis.
Due to major complexities in the manufacturing process and patient safety concerns, biologics were never included in the 1984 legislation that regulates the production and marketing of generic drugs. In 2010, Congress instructed the U.S. Food and Drug Administration to create an approval pathway for attempted copies, known as biosimilars. The agency could release its guidance any day now, ushering in America’s first copycat biologic drugs.