The Massachusetts Senate has passed legislation to allow pharmacists to substitute a biosimilar for a biological medicine when the United States Food and Drug Administration has determined that the two biological products are interchangeable and the prescriber has not instructed otherwise.
Following a substitution, the bill requires pharmacists to notify the prescribing practitioner and the patient. The bill will now go to the Governor for his signature.
Sounds good, right? Physician notification. But the bill was obviously drafted before the FDA expanded the types of biosimilars it will consider. Once upon a time there were two categories: biosimilar and interchangeable. But today there are four: not similar, similar, highly similar or highly similar with a fingerprint-like similarity -- depending on the type, nature and extent of any structural and functional differences revealed.
The reality is that “interchangable” is a thing of the past – even before it was a thing of the present.
In keeping with the spirit of the Massachusetts legislation (as well as that in many other states), the nomenclature should be reconsidered to reflect the realities of the evolving regulatory science.
