Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common throughout current legislation: interchangeability, indications to “Dispense as Written,” physician communication, patient notification, and recordkeeping. This Note goes on to argue that states without biosimilar substitution laws should embrace all of these provisions, except to the extent that notification provisions would allow patients to opt out of biosimilar substitution without a legitimate medical reason. If states can appropriately balance promoting biosimilars in the market while protecting patients’ safety, they can help more patients receive effective treatments while reducing spending on drugs.
Gary M. Fox,
Suggestions for State Laws on Biosimilar Substitution,
Mich. Telecomm. & Tech. L. Rev.
Available at: https://repository.law.umich.edu/mttlr/vol24/iss2/4