California, Illinois propose biosimilar substitution bills

By Zachary Brennan

- Last updated on GMT

Photo from Schoolhouse Rock
Photo from Schoolhouse Rock

Related tags United states

More than a year since California saw its previous biosimilar substitution bill vetoed by its governor and more than two years since Illinois tried its hand, both are again looking to become the ninth and tenth states to see new substitution laws.

Twenty-one states have now tried or passed legislation that generally calls for biosimilars to be declared interchangeable to their biologic counterparts by the US FDA. Most of the legislation also enables prescriber control of the biosimilar switch and calls for pharmacists to notify prescribers when a switch between a biologic and biosimilar is made.

Only one biosimilar in the US -- Novartis subsidiary Sandoz’s version of Amgen’s Neupogen (filgrastim) – has made it through an advisory committee meeting​ with the US FDA.


The Illinois bill​ says that pharmacists can only substitute biosimilars for a prescribed biologic if the US FDA determines the two to be interchangeable, the prescribing physician doesn’t prohibit the switch, the cost is less, the patient is informed, and the prescriber is informed within three business days of the name and the manufacturer of the biosimilar. Pharmacies also need to keep a written record of the interchangeable biosimilar for five years.

A previous Illinois Senate bill died in 2015 after being read a number of times in 2013​.

California Bill

Introduced last Friday in the state Senate, the California bill​ has all of the same requirements as the Illinois bill but it does not mandate any timelines for when prescribers must be notified, nor does it mandate the keeping of any records of biosimilar prescriptions by pharmacists.

But the California bill would require the California State Board of Pharmacy to maintain on its public Internet Web site a link to the current list, if available, of biologics determined by the FDA to be interchangeable.

The FDA previously took issue with the California bill that passed the state legislature​, saying “efforts to undermine trust in these products is worrisome​.” A spokeswoman said that the 2010 law creating the biosimilar pathway “expressly states that an interchangeable biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product​.”

New Jersey is the only other state​ with a biosimilar substitution law pending in its legislature, according to the National Conference of State Legislatures.

Related topics Markets & Regulations Biosimilars

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