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Posted on May 1, 2017 at 9:59 AM

The development of ‘specialty drugs’
in the health care industry has created legal, ethical, and public policy
issues because patients are not able to get access to their prescribed
medications based on the expense.  Specialty
drugs are usually biologicals, treat serious conditions, and  are very expensive with no cheap
alternatives.[1] Although there is debate
about how much finances should influence medical decision making, it is a
conversation that can not be ignored when patients can not get access to
treatment based on ability to pay. There should be increased access to these
drugs but how to increase access is up for debate.

One posed solution has been the
creation of biosimilar which are the generic version of a specialty drug. A
biological medication is different from a traditional drug in molecular make
up.[2]  “A biologic drug is ‘a substance that is made
from a living organism or its products[,]’”[3]  while a traditional prescription drug is made
up of simple molecules.[4]  This difference means that biologicals are
scientifically more difficult to produce because a more elaborate research is
necessary.[5]  This also means making a generic form, known
as a biosimilar, is more expensive and harder to make.[6]
Generally, a biological is “twenty times more expensive per patient than
traditional small-molecule pharmaceuticals.”[7]
There also are patent infringement concerns when making biosimilar.


From ethics perspective, one of the
key aspects of justice is ensuring equal access to healthcare or at least
fairly allocating available resources. For biosimilar drugs, it truly depends
on what insurance company, what insurance plan, and what pharmacy benefit
manager the patient has as to whether the patient will even have a chance to
get these drugs. One could argue that it is hard to say we have a fair
allocation system when it dependent on what backroom deals pharmaceutical
companies have with insurance companies. On the other side, fairness includes
ensuring that pharmaceutical companies are properly compensated for their time,
energies, and resources used to develop these drugs. Yes, they are cheaper than
brand name biologics but they are still expensive and arguably unaffordable. Competition
has been the suggested method for decreasing prices to ensure better access.
However, patents exclusivity and the Food and Drug Administration approval
process make competition slow.


On April 27, 2017, The United States
Supreme Court heard a case that addresses exactly this issue of access. The
Court heard oral arguments in regards to an appeal by Novartis, Swiss pharmaceutical
company, requesting the time for biosimilars to be on the market be sped up.[8]
Amgen, a California pharmaceutical company who makes the name brand version
Neupogen, had challenged the early release. The lower court decision had ruled
in favor of Amgen, preventing Novartis from releasing its biosimilar until six
months after the Food and Drug Administration approved it. The case revolves
around a provision in the Affordable Care Act which aimed at creating an
expedited path for approval of biosimilar drugs. The goal was to increase
access of new innovations to the public as well as increase competition to
decrease price. Zarxio, the biosimilar version of Neupogen, is projected to cost
15 percent less than Neupogen, which is a decrease in cost but not a
substantial in cost. Part of the issue is health insurance companies expect
biosimilar drugs to work like generic medications and they do not. Biosimilars
themselves are still innovation and companies charge for the research and
development that goes into innovations. The final decision is due to come in
June and this case could determine whether justice will be respected in regards
to how quickly consumers can get access to biosimilars.


[1] Joseph J. Hylak-Reinholtz
& Jay R. Naftzger, Is it Time to Shed
a “Tier” for Four-Tier Prescription Drug Formularies? Specialty Drug Tiers May
Violate HIPAA’s Anti-Discrimination Provisions and Statutory Goals
, 32 N. Ill. U.L. Rev. 33, 35 ? 36 (2011); Jim Sabin, How the U.S. Rations “Specialty Drugs,” Health Care Org. Ethics (Saturday, April
26, 2008)

[2] Michael Callam, Who Can Afford it?: The Patient Protection
and Affordable Care Act’s Failure to Regulate Excessive Cost-Sharing of
Prescription Biologic Drugs
, 27 J.L.
& Health
99, 103 (2014).

[3] Id.

[4] Id.

[5] Id. at 104.

[6] Id.

[7] Callam, supra note 2, at 105.

[8] Andrew Chung, U.S. Top Court Grapples Over Making Copycat
Biologics Available Sooner
, Reuters
(Apr. 26, 2017),


The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI’s online graduate programs, please visit our website.

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