Ruling sparks more debate on biogenerics

A recent court ruling demanding that the FDA take action on an application for a biogeneric version of a human growth hormone is forcing a fresh look at how the U.S. can start down the road to less expensive knockoffs of biotech drugs. Critics say that even subtle differences in biotech molecules can create serious risks. Others point out that insulin and human growth hormones are among the simplest molecules and are therefore most likely to lend themselves in the near term to a biogeneric competitor. The FDA, meanwhile, has dropped one biogeneric initiative and no one seems completely sure just where the agency is headed.

- read the report [1] from the Boston Globe