From The Corner Lab - Blog Posts

Virginia Law Is Nation’s First Dealing With Substitution of Biosimilars

Posted by Jim Menoutis on Fri, Apr 05, 2013 @ 11:32 AM

A new Virginia law is the first in the country that would prevent the automatic substitution of non-interchangeable biosimilars. Pharmacists substituting an interchangeable biosimilar for a brand product would need to inform the patient prior to the switch. Amgen and Genentech have been pushing state legislators to enact measures, including Virginia’s H.B. 1422, but the generic industry says such rules will create hurdles for the uptake of biosimilars.

In a similar action, the Florida Senate Committee on Health Policy passed S.B. 732, sending it to the full state senate. The legislation would require pharmacists to inform doctors when a follow-on biologic was substituted for a brand-name biotech drug. The bill is similar to one signed into law by Virginia.

Like the Virginia law, the bill in Florida has a five-year sunset clause stating it will expire in July of the fifth year after the Food and Drug Administration's approval of a follow-on biologic as interchangeable with a branded biologic.

Topics: biologic drug generic drug, branded drug, Biosimilars