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Massachusetts bill would OK biosimilar substitutes

June 22, 2014

BOSTON (AP) — A bill that would let pharmacists substitute a so-called biosimilar for a biological medicine has been sent to Gov. Deval Patrick’s desk.

The Massachusetts Senate gave final approval to the proposal Thursday.

The bill would allow the substitution when the federal Food and Drug Administration has determined that the two biological products are interchangeable and the prescriber has not been instructed otherwise.

The bill also requires pharmacists to notify the prescribing practitioner and the patient if there has been a substitution.

Biological medicines are used to treat diseases and health conditions and are generally made from human or animal materials.

A biosimilar is a biological medicine that is highly similar to an already approved biological medicine and has no clinically meaningful differences with regard to safety, purity and potency.

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