FDA's plan to boost cheaper copycat drugs could stall at the patent office

While the FDA is streamlining regulation of copycat versions of the expensive drugs that millions take for arthritis, cancer, and other diseases, the U.S. patent office is making it harder for the cheaper medicines to get on the market, industry officials say.

These officials were thrilled Oct. 29 when FDA Commissioner Marty Makary announced the agency's plan, which he said would halve the time and money needed to get what are called "biosimilar" drugs to market. Biosimilars are essentially generic versions of biologics — such as Humira, Keytruda, and Xolair — which are made from living organisms. Biosimilars can cost up to 90% less.

Under the guidance the FDA proposed, the agency would begin overseeing biosimilars similarly to the way it regulates generics, which are copies of simpl