presentation, I emphasized the need to inform patients and providers alike of
medication substitution even after a biosimilar is deemed interchangeable to
a biologic.
99 Amgen and the physicians echoed my concerns. Sandoz’s
representative took a more skeptical approach to biosimilar restrictions.
A closer examination of the stakeholders who advocate for state biosimilar
legislation on the grounds that it is patient-friendly is needed. Invocation of
patient safety concerns may be nothing more than a rhetorically effective way
to advance laws that may not actually help or protect patients.
A. Biologic Companies
Biologic manufacturers have been vocal supporters of state biosimilar
legislation.100 Critics argue that the Biotechnology Industry Organization
(BIO) “has waged a vast campaign at the state level to impose burdensome
requirements on pharmacists seeking to substitute FDA-approved
interchangeable biosimilars for biological products.”101 This is true even
though there are currently no FDA-approved interchangeable biosimilars.
BIO lobbies on behalf of over 1,100 biotechnologies around the world.102
BIO’s lobbying efforts helped pass the first state-level biosimilar legislation
in Virginia.103 Pharmacists opposed the law, arguing that it created “too much
red tape for substitution, thereby threatening the impact of biosimilars within
the state.”104 In California, the entities lobbying for the bill’s passage
included AbbVie, Amgen, BIO, Genentech, and PhRMA.105 Relying on their
“political power and insider influence,” companies like Amgen seek to
reduce competition and protect its market share.106
With respect to biosimilars, biologic manufacturers have an easily
discernible goal: stop the introduction of products that would threaten their
market share.107 Labeling laws that might limit patient access as “patient-
(explaining the procedural history of Amgen’s litigation over Sandoz’s biosimilar).
99. In 2015, I ended my relationship with GHLF. See supra note 2.
100. PUBLICCITIZEN,COMPETITIONINHIBITORS:HOWBIOLOGICSMAKERSARE
LEVERAGING POLITICAL POWER TO MAINTAIN MONOPOLIES AND KEEP PRICES SKY-HIGH 24
(2014), http://www.citizen.org/documents/report-biologics-industry-leverages-political-power-to-maintain-monopolies-and-inflate-prices.pdf.
101. Id.
102. Kate Traynor, Virginia Passes Nation’s First Biosimilar Substitution Law, AM.
SOC’Y HEALTH SYS. PHARMACISTS (May 15, 2013),
http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=3892.
103. Id.
104. Virginia Bill First to Allow Biosimilar Substitution, PHARMACY TIMES (Apr. 18,
2013), http://www.pharmacytimes.com/publications/issue/2013/april2013/virginia-bill-first-
to-allow-biosimilar-substitution.
105. PUBLIC CITIZEN, supra note 100, at 26–27.
106. Id. at 27.
