NEW YORK — While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.
In a post Friday on FDA Law Blog, the official blog of the law firm Hyman, Phelps & McNamara, attorney Kurt Karst wrote that several states were laying the groundwork for such legislation, recalling state-level antisubstitution laws targeting generics that were adopted in the 1970s.
"State legislation concerning the substitution of an interchangeable biosimilar product for the brand-name reference product counterpart has already started cropping up, and 2013 may be the year when legislation takes off and is enacted," Karst wrote, naming Illinois and Virginia as two examples of such states.
In Illinois, a bill that didn't pass last year but may be introduced this year would allow a prescribing physician to prohibit dispensing a biosimilar and would require the pharmacist to notify the prescriber while both would have to keep a written record of the biosimilar substitution for at least five years. The Virginia legislation, which Karst described as "moving along," would require a pharmacist dispensing a biosimilar in place of a branded biologic to inform the patient and the physician within five days of dispensing.