The Public Health and Welfare Committee of Pennsylvania’s Senate has approved a bill (S.B. 405) that imposes certain requirements on the substitution of biosimilars for a "prescribed brand name biological product." The bill will next go to the full senate for a vote. The bill’s core provision, like its counterparts in other states, allows pharmacists to substitute biosimilars for a pioneer biologic only when the U.S. Food and Drug Administration deems the treatments functionally interchangeable. Biosimilars, also known as follow-on biologics, serve as the generic equivalent of biologic drugs, which are either made by, or derived from, living organisms. Under current Pennsylvania law, pharmacists may treat biosimilars like any other generic drug, with substitution permitted unless a doctor specifies that the brand-name drug is medically necessary.
Sponsored by Sen. Patricia Vance (R-Cumberland), the bill also requires pharmacists to notify patients and physicians of the substitutions and to maintain such records. Evidently, the rationale for notification is that biosimilars, unlike traditional generics, may not function exactly like their brand-name versions. Bill proponents maintain that doctors should be aware when biosimilars are used so they can be alert for diminished safety or effectiveness. Similar bills have reportedly flooded statehouses around the country this year, although only a few have become law. These measures have reportedly been approved in North Dakota, Oregon, Utah, and Virginia, although sunset provisions were adopted in the latter three. See Law 360, November 15, 2013.