ARTICLE | Regulation

The confiscation gambit

July 18, 2005 7:00 AM UTC

While Europe's EMEA has been busy laying the ground rules for biosimilars, the status of follow-on biologics remains far murkier in the U.S. Legal ambiguities and a much more politically potent innovator industry have prevented FDA from advancing an FOB strategy as quickly as its European counterparts (see Cover Story).

As a result, the conflict is fiercer between companies seeking to promote and block FOBs on American soil as the combatants lay the groundwork for battles at the FDA, in Congress and in the courts that will determine the conditions under which off-patent versions of biologics could be marketed. ...