ISTOCKPHOTO, SJLOCKE
As one of the first class of biologic drugs to reach the marketplace, interferon-a–based products were among the first whose patents have expired. Many other biological therapies have already lost or will lose their patent protection and begin to face competition from generics. How to regulate generic versions of biologics—known as biosimilars—is still very much a matter of debate.
Since 1984, the US Food and Drug Administration has permitted generic drug manufacturers to submit Abbreviated New Drug Applications (ANDAs) to demonstrate that a proposed generic drug is bioequivalent to the brand-name drug. Generally speaking, this has relieved generic manufacturers of the cost of conducting a full clinical-trial program, relying instead on the safety and efficacy record established by the branded product.
But biologics, or biologically ...
