Philip J. Schneider, MS FASHP
ASBM Advisory Board Chair
This week, West Virginia Governor Jim Justice and Wisconsin Governor Scott Walker signed bills updating pharmacy regulations in their respective states. The new laws permit pharmacists to substitute interchangeable biosimilars in place of an originator biologic medicine when they are approved by the FDA.
The signing of this legislation means that 41 states and Puerto Rico now have these important measures in place to pave the way for interchangeable biosimilar use while also maintaining the highest standards for patient safety. 93% of Americans can now immediately gain access to affordable new treatment options once the FDA deems a biosimilar as interchangeable. Each of the states who have added these measures to the books require the timely communication between healthcare providers about which medicine are dispensed, promote the maintenance of an accurate patient record, and preserve a physician’s authority to prevent an inappropriate substitution.
It’s quite a change from when I first became involved with ASBM in September of 2012. At that point, not a single biosimilar had been approved in the U.S., and not a single state had yet updated its Pharmacy Practice Act to permit biosimilar substitution.
From 2013 to 2014, eight forward-thinking states (Delaware, Florida, Indiana, Massachusetts, North Dakota, Oregon, Utah and Virginia) led the way by updating their state pharmacy regulations to allow the safe substitution of interchangeable biologics by acknowledging the need for physician, pharmacist and patient communication in the process of administering these highly complex drugs.
Following the FDA’s approval of the first biosimilar, Zarxio (filgrastim-sndz) in March 2015 another 17 states (Arizona, California, Colorado, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Missouri, New Jersey, North Carolina, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Washington) and Puerto Rico had enacted laws by the end of 2016. At that point, the FDA had approved four biosimilars.
In 2017, 11 more states followed (Iowa, Kansas, Maryland, Minnesota, Montana, Nebraska, Nevada, New Mexico, New York, Ohio and South Carolina). That year the FDA released its Guidance on Interchangeability and approved an additional five biosimilars, bringing the total to nine.
Now as we end the first quarter of 2018, we already have bills in five more states (South Dakota, Michigan, Wyoming, West Virginia and Wisconsin) having been signed into law. Now we are in the home stretch, with only nine states still in need of updating their pharmacy laws.
Over the past five and a half years, it’s been my privilege to work with state legislatures and Boards of Pharmacy to make that happen. As we near the inevitable FDA approval of the first interchangeable biosimilar, it is good to know we are almost at the finish line in ensuring all patients have access to potentially lower cost biologic drug alternatives, while making sure we do not compromise patient safety.