Understanding State Regulation of Biosimilars and Effect on Prescribers

October 2017 | Volume 16 | Issue 10 | Original Article | 995 | Copyright © October 2017

Katerina Yale BA,a Olabola Awosika MD MS,b Monica Rengifo-Pardo MD,a,b and Alison Ehrlich MD MHSa,b

aGeorge Washington University School of Medicine & Health Sciences, Washington, DC bDepartment of Dermatology, The George Washington Medical Faculty Associates, Washington, DC

Biologics are a mainstay of treatment for many dermatologic conditions, however the high costs can be prohibitive for many patients. A growing market of biosimilar drugs is emerging with the hope of providing patients access to more affordable medications. While the FDA has created an abbreviated licensure pathway for these drugs, states are still in the process of creating regulations regarding their substitution for reference biologics. This article looks to raise awareness of the current federal regulations and the differences among state regulations regarding the use of biosimilars. Fifty percent of states have passed legislation regarding procedures for substitution of biosimilars in the pharmacy. All states require biosimilars to have FDA-approved “interchangeable” status, however states vary on other requirements such as: prescriber and patient notification, pharmaceutical record keeping, publicly-accessible list of interchangeable products, and cost regulations. Some of the issues surrounding biosimilar regulation include difficulty obtaining interchangeability status from the FDA, resistance to the physician notification requirement, and concern for traceability of adverse reactions. Physicians must be aware of current federal and state regulations regarding biosimilars and help inform policy makers of the potential benefits and shortcoming of biosimilar legislation.

J Drugs Dermatol. 2017;16(10):995-1000.


Biosimilars are biological products that are highly similar to, and have no clinically meaningful difference from, an already FDA-approved biological product.1 Specifically, biosimilars are highly complex proteins derived from living cell lines which share pro les that are comparable to, but not identical in safety and efficacy, with their reference biologic.2,3 In 2016, Inflectra®, Erelzi®, Amjevita® were approved by the Federal Drug Administration (FDA) as biosimilar agents to infliximab, etanercept, and adalimumab, respectively.4 In April 2017, a second biosimilar to infliximab, Renflexis®, was approved by the FDA.5 These biosimilars can be prescribed for the same indications as the proprietary drugs, such as plaque psoriasis, making them potential alternatives for dermatology patients. With biosimilars rapidly emerging on the United States (U.S.) pharmaceutical market, dermatologists should be aware of the current federal regulations and the differences among state regulations regarding the use of biosimilars.In 2010, the Public Health Service Act was amended to create an abridged licensure pathway for biological products that are determined to be “biosimilar to” or “interchangeable with” an FDA approved biologic.1 Through the Biologics Price Competition and Innovation (BPCI) Act, biosimilars are approved without extensive animal and human testing, but have no right to patent privileges. Important conditions exist for this process: (1) for a biosimilar to be considered “interchangeable” it must produce the same clinical result in any given patient; and (2) the risk of diminished efficacy or safety when switching between use of the biosimilar and the reference biologic must not be greater than the risk of using the reference biologic without such a switch.In January 2017, the FDA released draft guidance for biosimilar drug companies that suggests execution of switching studies to demonstrate achievement of interchangeability without diminished efficacy or safety.

Current State Legislation

While the FDA regulates biosimilar approval, states are responsible for legislation on pharmacy procedures regarding substitution of reference biologics with biosimilars. By the end of 2016, twenty-five states had enacted such laws. Many of the states simply amended their previously-existing bills concerning regulation of generic medications to include biosimilars, along with a few additional requirements specific to biologics. These state regulations are outlined in the Table. For each state with biosimilar legislation, biosimilars must be FDA-approved as interchangeable before substitution can occur. 7 Each state also requires pharmacists to communicate with the prescriber after a substitution is made. However, state laws differ on the amount of time required for notification. For example, Hawaii pharmacists have 24 hours for communication, while Colorado requires noti cation “in reasonable time.” Regarding patient notification, all enacted statutes require that the patient be notified when a substitution is made. Delaware, for example, requires patient written consent before

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Table 1