By Stu Hutson

The Biologics Price Competition and Innovation Act, signed into US law last March, gave the country’s drug regulators the authority to establish a pathway to approving ‘generic versions’ of biologic drugs. Now the US Food and Drug Administration (FDA) must take the next step and set guidelines for evaluating these large, complex organic molecules that are almost—but not quite—copies of some of modern medicine’s most important drugs.

As the FDA held a public hearing about the abbreviated pathway for these biosimilars earlier this month, many industry analysts were examining the agency’s recent favorable decisions regarding generic versions of the biologic drugs Lovenox (Sanofi Aventis) and Neupogen (Amgen). Although these biosimilar versions might have received an easier pass than many suspected, some industry experts say that the drugs just represent low-hanging fruit.