An Update Regarding Follow-On Biologics

By Cliff Mintz, Life Science Leader magazine

The debate over whether or not lower cost, “generic” versions of biologics and biotechnology drugs ought to be brought to market has been a very long and contentious one. However, rising healthcare costs and demands for greater access to biotechnology drugs have finally induced Congress to consider legislation to guide approval of these products.

Discussions about these molecules began in earnest in the late 1990s when generic manufacturers determined that several blockbuster biotechnology drugs, including human growth hormone (hHGH), erythropoietin (EPO), and granulocyte colony stimulating factor (G-CSF), would soon lose patent protection. This prompted a careful review of the U.S. Drug Price Competition and Patent Term Restoration Act (better known as the Hatch Waxman Act) to determine whether or not generic biologics could be approved by this legislation. It quickly became apparent that Hatch Waxman didn’t provide a clearly defined, regulatory approval process for so-called biogeneric drugs. This marked the beginning of an almost decade-long and often acrimonious debate that pitted innovator biotechnology companies against generic drug manufacturers.