FDA finalizes rules on when biosimilars can be interchangeable with biologics

The FDA has released its final word on the kinds of studies that biosimilar makers will have to conduct in order to be considered interchangeable with biologic drugs, which are made from living organisms and often come with a high price tag. Just as generics are a cheaper alternative to brand-name drugs, biosimilars are an alternative to biologics, but without the “interchangeable” designation, pharmacists can’t automatically swap out biologics for biosimilars. Among the new rules, biosimilar makers will have to do so-called switching studies, in which patients in trials switch back and forth between the biologic and the biosimilar to show no adverse effects on the patients. Some major biosimilars group have welcomed the move, while others have lamented that the new FDA rules may mean more of a burden for biosimilar makers to get their product to market.