As of December 2016, four products have been granted a biosimilars
license: Amjevita, Erelzi, Zarxio, and Inflectra.
64 These products are
biosimilar to, respectively, Humira, Enbrel, Neupogen, and Remicade.
date, no biologics have been deemed interchangeable.
B. State Regulation
States have considered biosimilar naming and whether to impose “patient
consent, recordkeeping, and physician notification requirements.”
legislation regarding biosimilars has certain common features.
68 First, state
laws permitting substitution of a biosimilar require that the FDA has deemed
the biosimilar interchangeable, a step the FDA has yet to take.
69 Second, state
laws often give the prescriber the ability to prevent substitution.
70 Third, state
laws generally require some form of provider notification if substitution
71 At least twelve states require patient notification.
72 Fourth, state
laws mandate that pharmacists keep additional records regarding biosimilar
Industry, 100 KY. L.J. 635, 685 (2012); JOHN GLADSTONE MILLS III ET AL., PATENT LAW
BASICS § 12: 20 (Rev. ed. 2016); Brian F. King, Emerging Market for Biosimilars: State
Legislation Should Reconcile Biosimilar Substitution Laws with Existing Laws on Generic
Substitution, 18 DEPAUL J. HEALTH CARE L. 31, 36 (2016).
64. CTR. FOR DRUG EVALUATION & RES., LIST OF LICENSED BIOLOGICAL PRODUCTS WITH
( 1) REFERENCE PRODUCT EXCLUSIVITY AND ( 2) BIOSIMILARITY OR INTERCHANGEABILITY
EVALUATIONS TO DATE
65. Id. (showing that the proper name for the biosimilar is the same as the biologic, just
with the 4-letter suffix); Zachary Brennan, FDA Approves Third Biosimilar in US, First for
Amgen’s Blockbuster Enbrel, REG. AFF. PROF. SOC’Y (Aug. 30, 2016),
Biosimilar-in-US-First-for-Amgens-Blockbuster-Enbrel/ (describing approval of Erelzi and
Zarxio); FDA Approves Amjevita, a Biosimilar to Humira, U.S. FOOD & DRUG ADMIN. (Sept.
(describing Amjevita approval); Sy Mukherjee, Why These Copycat Drugs Aren’t Slashing
Best-Sellers’ Prices, FORTUNE (Oct. 18, 2016), http://fortune.com/2016/10/18/pfizer-johnson-
johnson-remicade-biosimilar/ (describing limited savings offered by Remicade biosimilar
66. FDA Finally Addresses Interchangeable Biosimilars, LAW360 (Feb. 28, 2017),
67. Shepherd, supra note 16, at 152.
68. Richard Cauchi, State Laws and Legislation Related to Biologic Medications and
Substitution of Biosimilars, NAT’L CONF. OF ST. LEGISLATURES. (Nov. 15, 2016),