On April 22nd, Oklahoma Governor Kevin Stitt signed SB 4, making Oklahoma the 50th and final state to enact a law permitting biosimilar substitution.
SB 4, like similar legislation in other states, permits interchangeable biosimilars to be substituted at the pharmacy level once approved by the FDA. Patients and physicians must be informed of a substitution, and one may be prevented by the physician if deemed medically necessary.
The substitution of medicines is governed at the state level, but state pharmacy acts were written before the advent of biosimilars and did not reflect their differences from generics of small-molecule drugs. Updating these acts nationwide has been a 10-year endeavor involving the collaborative efforts of many patient advocacy organizations, physician and pharmacist societies, manufacturers of originator products and biosimilars, and many other stakeholders.
ASBM has worked since 2011 to educate policymakers nationwide by sharing with them the perspectives of the physicians that prescribe biologics, the pharmacists who dispense them, and the patients who receive them.
ASBM’s efforts in this decade-long campaign consisted of three nationwide physician surveys, the gathering dozens of patient testimonials, physician and pharmacist interviews, innumerable letters and legislator briefings, meetings with state medical and pharmacy societies, in-person expert testimony before state legislatures, educational videos, and holding countless educational forums at colleges of medicine and pharmacy.
As ASBM Executive Director Michael Reilly observed:
“This 10-year educational campaign spanned the terms of three ASBM Chairmen and touched every single U.S. state and territory. Today marks the end of a long journey- and a fully-realized victory for patients, as the protections of this legislation now reach nationwide.”
Read about Oklahoma’s SB4 here.
Read about biosimilar substitution laws nationwide here.