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The FDA is laying the foundation for generic versions of biotechnology medicines. This action could eventually change the market for some of the most pioneering and costly new treatments for cancer and other diseases, according to an article in the Wall Street Journal (February 18, 2004). IMS Health reported that the market for biotechnology drugs totaled $22.3 billion in the 12 months that ended in November 2003.
Currently, there is no process in place for the FDA to approve generic versions of biotech drugs, which are produced through very complicated methods, compared with regular pharmaceuticals. Because the brand name biotech industry is little more than 25 years old, it has had to battle low-cost generic copies of its drugs, and consumers have not gotten the price breaks that come with such competition.
Now, however, with some of the oldest biotech drugs beginning to lose patent protection, the FDA is starting to set the stage for follow-on drugs. The FDA is in the process of putting together scientific guidelines on how to prove that copies are similar to the original medicines.