The proposed bill – HB 5598 – would allow pharmacists in Michigan to switch from a biologic to a lower-cost biosimilar if it’s available in the pharmacy. The bill does not place any further requirements on pharmacists in terms of notifying physicians of the switch, though it does require pharmacists to not make the switch to a biosimilar if the prescriber has indicated that the drug should be “dispensed as written.”
The bill also requires that the pharmacist notify the purchaser of the biosimilar if a switch is made, and to notify them of the manufacturer and the distributor of the biosimilar if they are available.
In addition, the bill says a pharmacist “shall not dispense a drug product” that is more expensive than the one prescribed, which should not be an issue for biosimilars, which are intended to be cheaper than their biologic counterparts.
Patchwork of Laws
The Michigan bill does not seem to stray too far from the pack of bills making their way through other states and seems most similar to a Massachusetts bill that allows for biosimilar substitution as long as the biosimilar has been approved by the US FDA.
The bill, however, differs from other states with more onerous restrictions on when a pharmacist is allowed to substitute a biosimilar, who must be contacted and how long records must be kept if a substitution is made. For instance in North Dakota, pharmacists must notify physicians within 24 hours of when a substitution is made. Similarly, Indiana passed a law – backed by the biotech industry -- that requires physicians to provide explicit consent for a biosimilar switch in order for the pharmacist to make the switch
Utah, Indiana and Virginia also offer varying laws that require pharmacists to inform prescribers if there’s a biosimilar substitution.
All of this action at the state level comes as the US FDA has yet to even approve a biosimilar, which has caused some concern that there might be conflicts between state and federal statutes.
A full breakdown of the state-by-state moves in regards to biosimilar substitution also reveals how many states -- including Arkansas, Colorado and California -- have proposed and then later rejected such legislation.
For California, Governor Jerry Brown vetoed pending legislation, calling it premature.