High health care costs are one of those problems that everybody recognizes, and the high cost of pharmaceuticals is a significant contributor to it. The intensive regulatory process drugs have to go through before being approved not only raises prices for consumers, but keeps potentially life-saving medicine off the market for years at a time, even when similar drugs have been approved in Europe, where the regulatory process is different.
A prime example of this involved complex drugs known as “biosimilars,” which are essentially lower-cost copies of proprietary drugs made from living cells. Biosimilars are basically equivalent to a generic version of a brand name drug produced after the original patent runs out.
Unlike conventional medicines made from simple chemical compounds, the living component introduces new complexities into the types of testing required by the Food and Drug Administration. While the FDA had previously approved certain biologic drugs, the manufacturing process was held to be too complex to allow generic versions to enter the market.