theme: without the new legislation, patients’ safety would be at risk.
I testified in support of HB 319 on behalf of GHLF during a Health and
Welfare Committee hearing, as did a physician. In addition to my testimony,
I gave a radio and television interview in support of the proposed bill.
As far as I am aware, only one organization opposed the Louisiana bill.
The Academy of Managed Care Pharmacy contended that it “would place
unnecessary restrictions on the substitution of biosimilars determined to be
interchangeable with reference biologic products by the [FDA].”
instance, Louisiana Pharmacy Practice Act’s definition of “biologic product”
references the BPCIA’s definition, but makes no distinction between
biosimilar and interchangeable products, a key distinction under the
95 As explained above, a pharmacist cannot substitute a biologic for
a drug that is only biosimilar to the biologic, but may exchange a biologic for
a biosimilar if the biosimilar is interchangeable.
Moreover, pursuant to the Louisiana Pharmacy Practice Act, if a
pharmacist substitutes a biosimilar deemed interchangeable by the FDA, the
pharmacist must “[n]o later than five business days following the dispensing
of a biological product . . . communicate to the prescriber the specific product
provided to the patient, including the name of the product and the
96 Ultimately, Representative Simon’s bill was signed into law
on July 1, 2015.97
After my experience in Louisiana, I was tapped by GHLF to participate in
the Congressional Arthritis Caucus’ July 13, 2015, Biosimilar Briefing. I was
joined by two rheumatologists, one representing the Arthritis Foundation and
the other representing the Coalition of State Rheumatology Organizations, as
well as representatives from Amgen and Sandoz. During pre-briefing
organizational calls, I gleaned that GHLF’s interests aligned with those of
Amgen and the rheumatologists. I asked whether state biosimilar laws might
be preempted by federal law and was asked to refrain from raising the issue
at the Biosimilar Briefing.
At the time, Amgen and Sandoz were engaged in litigation over a Sandoz
biosimilar that would compete with an Amgen biologic.
98 During my panel
(May 7, 2015, 3: 15 PM),
94. Letter from Edith A. Rosato, Chief Exec. Officer, Acad. of Managed Care Pharmacy,
to Governor Bobby Jindal, State of La. (June 17, 2015),
95. LA. STAT. ANN. § 37:1164( 4) (2016).
96. LA. STAT. ANN. § 37:1226.1( A).
97. Press Release, Coal. of State Rheumatology Orgs., supra note 90.
98. See John T. Aquino, Court Ends Amgen’s ‘Pointless’ Biosimilar Suit Against Sandoz,
BLOOMBERG BNA (July 26, 2016), https://www.bna.com/court-ends-amgens-n73014445282/