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18 States Down, 32 to go for Biologics Legislation

Posted: February 1, 2016

2015 saw the vast majority of interested parties coalesce behind a common framework of interchangeable biologics legislation. With this unified backing, CSRO was involved in passing legislation in 11 states. This brings total number of states with active laws on interchangeable biologics to 18 and Puerto Rico.

The model legislation developed by this coalition covers the vast majority of items that CSRO had requested for this legislation. This includes notification to the physician about exactly which medication was dispensed, notification and/or labeling of the drug for the patient, record keeping by the pharmacy, the ability for a physician to prevent substitution through “dispense as written,” and only substituting for FDA approved interchangeable biologics.

The only opposition CSRO faces in most states is from the pharmacy lobby who continues to try and counter that this legislation will be burdensome, is intended to scare people away from lower cost biosimilars, and is not wanted by physicians. There is also intermittent resistance from health plans in a few locations. These arguments tend to be relatively weak, especially in the case where direct testimony from physicians to counter many of the opposition claims.

For 2016, legislation is expected in at least 13 states with bills currently active in Arizona, Hawaii, Kentucky, Michigan, Missouri, Nebraska, New York, Oregon, and Pennsylvania.