required physician notification within five days after a biosimilar was
exchanged for a biologic.
33 Since then, my perspective on laws like the one
passed in Louisiana changed. I no longer think that notification is necessary.
In fact, I am concerned that notification provisions only impede patients’
access to biosimilars. Biologics are often shipped to patients by specialty
pharmacies. There is some delay between the time a medication is prescribed
and when it is received—shipping from a special pharmacy requires the
pharmacy to verify when the patient can receive the medication, as it often
needs to be refrigerated upon arrival. Until that information is received, the
medication will not ship. Once it ships, unless a patient pays for express
delivery, the medication arrives within several days of mailing. A patient
may receive notification of an exchange before she receives the medication
itself. This abnormal procedure may discourage the patient from taking a
required dose on time, and may delay or halt future use of the biosimilar. The
notification provision communicates to the patient that something is amiss,
and may dissuade the patient from accessing an equally effective and
potentially cheaper form of treatment.
This article is inspired by my experience as a patient and advocate. It
identifies the stakeholders who have shaped state biosimilar legislation and
argues that not all stakeholders are represented.
Following this introduction, Part II compares federal biosimilar regulation
with state biosimilar regulation. Part III describes the flaws of state biosimilar
regulation. The essay concludes with a recommendation that state legislative
hearings and access to state legislators considering sponsorship of biosimilar
legislation be driven by patient voices and patient demands.
II. BIOSIMILAR REGULATION
Biosimilars are regulated through both federal and state legislation.
Federal legislation established an abbreviated market license pathway for
biosimilars and set guidelines for the circumstances in which a pharmacist
may exchange a biologic for a biosimilar.
35 At the state level, legislation
33. LA. STAT. ANN. § 37:1164( 16), (58); 1226.1 (2015); Katherine Macfarlane, Patient
Advocate, Glob. Health Living Found., Testimony at House of Representatives Health and
Welfare Committee Consideration of HB 319 (May. 6, 2015),
34. Jesse C. Vivian, Legal Aspects of Biosimilars, 41 U.S. PHARMACIST 16, 17 (2016).
35. Information on Biosimilars, U.S. FOOD & DRUG ADMIN.,
oved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ (last updated May
10, 2016) (noting the Public Health Service Act was amended “to create an abbreviated
licensure pathway for biological products” that are biosimilar or interchangeable “with an
FDA-licensed biological product”).