Hospital Pharmacy - September 2017 - 544

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research-article2017

HPXXXX10.1177/0018578717726995Hospital PharmacyGabay

Rx Legal
Hospital Pharmacy
2017, Vol. 52(8) 544-545
© The Author(s) 2017
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https://doi.org/10.1177/0018578717726995
DOI: 10.1177/0018578717726995
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Biosimilar Substitution Laws
Michael Gabay1
Keywords
legal aspects, pharmacists, education, drug information
In 2010, the Patient Protection and Affordable Care Act was
enacted into law in the United States. A section of this law
amended the Public Health Service Act resulting in the creation of an abbreviated licensure pathway for biological
products found to be biosimilar to, or interchangeable with,
an existing Food and Drug Administration (FDA)-approved
biologic product.1,2 Per the FDA, a biosimilar is defined as "a
biological product that is approved based on a showing that
it is highly similar to an FDA-approved biological product,
known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the
reference product."1
Generally, biosimilars are only allowed to have minor differences in clinically inactive ingredients. Interchangeable
biologic products are biosimilar to a reference product as
well; however, these products are required to meet additional
standards to demonstrate interchangeability with the reference biologic.3 Basically, an interchangeable product "is
expected to produce the same clinical results as the reference
product in any given patient." In addition, for those products
that may be administered more than once, clinical data need
to show that switching a patient back and forth between the
reference and interchangeable products presents no greater
risk to a patient in terms of efficacy and safety when compared with continuously treating the patient with the reference product.
In March 2015, the FDA approved the first biosimilar
product in the United States-filgrastim (Zarxio). Since this
initial approval, 4 more biosimilars have become available
including 2 biosimilars for infliximab (Inflectra; Renflexis)
and 1 biosimilar each for etanercept (Erelzi) and adalimumab
(Amjevita).4 With the approval of these biosimilars, there has
been an increase in the number of state laws surrounding
appropriate substitution of these agents for an original biologic product. Many states have a concern that traditional
statutes regulating generic medications may be misapplied to
newly approved biosimilars that are not necessarily identical
to a reference product.5 Accordingly, in the past 5 years, at
least 45 states have evaluated legislation establishing standards for substitution of a biosimilar product for a reference
biologic. As of July 1, 2017, 35 states and the unincorporated
US territory of Puerto Rico have passed laws regarding biosimilar substitution requirements. The provisions of these
state laws vary, but there are several features and requirements that are often included such as the following5:

** Any biological product under consideration as a substitution for a reference product must first be approved
as "interchangeable" by the FDA.
** Prescribers must be able to prevent substitution by
writing "dispense as written" or "brand medically
necessary" on the prescription.
** Legislative language requiring that the prescriber
"must be notified" of any allowable substitution made
at a pharmacy or that the prescriber be "communicated with" regarding the substitution in some manner
such as a notation in an electronic medical record.
** Requiring that the individual patient be notified of the
biosimilar substitution or switch; at least 12 states
include this provision in their biosimilar substitution
laws. In addition, some state laws require that the
affected patient must give consent before such a substitution is made.
** Requiring that both the pharmacist and the prescriber retain records of the substituted biologic
medication.
** Providing immunity for pharmacists who make a biosimilar substitution in compliance with state law.
** Requiring the state to maintain a public or web-based
list of permissible interchangeable products.
** Ensuring that the pharmacist has to explain the cost of
the biologic and the interchangeable biosimilar to the
patient or prescriber; some states such as Colorado,
Georgia, Illinois, North Carolina, and Texas require
that any substituted product must be associated with
the lowest cost to the patient.
Currently, all 5 approved biosimilars in the United States
are not designated as interchangeable per the FDA; therefore, none of the state biosimilar substitution laws are applicable to dispensing decisions.5 A summary of biosimilar
substitution laws by state may be found at http://www.ncsl.
org/research/health/state-laws-and-legislation-related-tobiologic-medications-and-substitution-of-biosimilars.aspx.

1

The University of Illinois at Chicago, USA

Corresponding Author:
Michael Gabay, College of Pharmacy, The University of Illinois at Chicago,
833 S Wood Street, Chicago, IL 60612, USA.
Email: mgabay@uic.edu

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