South Dakota Passes Biosimilar Substitution Bill

In the United States, 9 biosimilars have currently earned FDA approval, with 3 available on the market today. Despite slower biosimilar uptake than originally projected, many states have been introducing legislation for the marketing and potential substitution of biosimilars in preparation for their increased availability and eventual interchangeable status. To date, 37 states and Puerto Rico have passed legislation on biologics and biosimilar substitution, according to the National Conference of State Legislature, with South Dakota becoming the most recent state to have its legislature pass a biologics and biosimilar substitution bill.

South Dakota Senate Bill 75, which is expected to be signed by South Dakota’s Governor, Dennis Daugaard-R, allows pharmacists to substitute an interchangable biosimilar for its reference without the intervention of the prescribing healthcare provider, unless the reference is specifically called for by the prescriber.

However, if a substitution is made, the pharmacist is required to notify the patient when the drug is dispensed (and inform the patient of their right to refuse the biosimilar), and must also notify the prescriber within 5 business days. In addition, the bill requires records of a biologic substitution to be kept either electronically or in hard copy, and provides guidelines for how to label such products (ie, using the product's proper name or brand name).

Senate Bill 75, as well as many other state bills follow the principles endorsed by Biotechnology Innovation Organization (BIO), a biotech industry trade group, which hold that substitution should occur only when the product has the FDA’s interchangeable designation, that prescribers should be able to prevent substitution, that physicians and patients should be notified if substitution occurs, and that good records of substitution must be maintained.

Senate Bill 75 was delivered to Governor Daugaard for signing on February 6.

BIO voiced its support for passage of the bill, saying in a statement that, while almost 90% of the US population is now covered by state laws addressing biosimilar substitution, it “…will keep up the pressure until all 50 states enact this important public policy.”