Seventeen U.S. states are considering legislation to create parameters for the substitution of a therapeutic biologic with its biosimilar counterpart, with the proposals in many cases more stringent than rules now in place governing generic substitutions for small-molecule drugs.
State Bills To Regulate Biosimilar Substitutions Make Headway
Seventeen states are considering legislation to set rules for biosimilar substitutions, including alerting the prescribing physician and keeping long-term records of the substitutions – steps that go beyond those in place for small-molecule generic drug substitutions.
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