California and Illinois Bills Take Opposite Approach to Biosimilar Substitution

Two state legislatures are considering biosimilar substitution bills, but are taking opposite approaches to the issues of prescriber notification and patient consent.

In California, legislation was introduced Feb. 27 that closely mirrors compromise substitution language negotiated between brand and biosimilar makers and unveiled by GPhA late last year.

The California bill would require pharmacists switching a brand for a biosimilar to make note of the swap in an electronic medical records database accessible by the prescribing physician. Only in cases where no electronic medical record was available would the physician be directly notified of a swap. This is the state’s second crack at biosimilar substitution after Gov. Jerry Brown (D) vetoed a bill that would have required prescriber notification.

Conversely, in Illinois, legislation was introduced Feb. 26 that would require pharmacies to notify prescribers of a swap within three business days. The bill would also give the patient the option of rejecting the biosimilar version outright.

Both bills would allow for substitution only if the FDA approved the biosimilar as interchangeable. Both would also allow the prescribing physician to specifically state that no substitution should take place.

The California bill makes no provision for pricing differences between brand and biosimilar. The Illinois proposal says a biosimilar may only be swapped if it’s more expensive than the brand if the patient explicitly accepts the higher cost.

GPhA and some biosimilar makers have pushed to avoid direct prescriber notification of a biosimilar swap because it would slow market acceptance of the therapies. So far, most of the eight states to pass substitution laws have accepted the GPhA position and treated biosimilars the same as generics.

The California bill (SB 671) can be read at www.fdanews.com/03-05-15-CaliforniaBiosimilars.pdf and the Illinois bill (HB 3519) is here: www.fdanews.com/03-05-15-IllinoisBiosimilars.pdf. — Bryan Koenig