AMCP Session Provides a Closer Look at State Legislation on Biosimilars

May 1, 2018
Jaime Rosenberg

During a session at the Academy of Managed Care Pharmacy’s (AMCP) Managed Care & Specialty Pharmacy Annual Meeting, held April 23-26 in Boston, Massachusetts, Reginia Benjamin, BS, JD, director of legislative affairs for AMCP, provided an in-depth look at state legislation on biosimilars.

During a session at the Academy of Managed Care Pharmacy’s (AMCP) Managed Care & Specialty Pharmacy Annual Meeting, held April 23-26 in Boston, Massachusetts, Reginia Benjamin, BS, JD, director of legislative affairs for AMCP, provided an in-depth look at state legislation on biosimilars.

Currently, 41 states and Puerto Rico have laws addressing biosimilars and interchangeable biosimilars, and 4 states still have bills pending, according to Benjamin. While there are 5 states that do not have biosimilar laws on the books, there is anticipation that 2 of those states will have a bill by 2019.

State legislation on biosimilars first arose in 2013, with 5 states taking the lead in developing and approving bills: Florida, North Dakota, Oregon, Utah, and Virginia. Three of the states—Utah, Oregon, and Virginia—had sunset provisions on their bills, meaning the bill would expire at the set date unless it was reenacted. All 3 bills would have expired before the first biosimilar was approved and introduced into the market, but they were reenacted by the states. By the time the first biosimilar was approved in 2015, 10 states had enacted biosimilar laws.

Benjamin then gave an overview of state legislative activity over the years. In 2013, the first biosimilar legislation required that the pharmacist notify the prescriber by either phone or fax within a specified period of time if they were going to dispense a biosimilar. There were also labeling requirements and additional record keeping that were not required for any other drug dispensed, according to Benjamin.

In 2014, new laws added provisions that notification could be achieved by adding a note into an electronic health record, so pharmacists would no longer have to phone or fax. In 2015, an entry into a pharmacy benefit manager’s system that was accessible to the prescriber was deemed as achieved notification, and in 2016, notification and labeling requirements arose for dispensing an interchangeable biosimilar. According to Benjamin, no additional provisions were added in 2017 or thus far in 2018.

Benjamin highlighted the fact that states do not use the FDA’s definition of interchangeable biosimilars. Instead, they refer to language in the Biologics Price Competition and Innovation Act (BPCIA), which references the standards of interchangeability.

State laws have also given interchangeability a 2-part definition: A biological product determined by the FDA to meet the standards of interchangeability set forth in the BPCIA, or a biological product determined by the FDA to be therapeutically equivalent as set forth by the FDA’s Orange Book—despite the fact that the Orange Book addresses small-molecule drugs and not biologics.

Additional state legislative language, which is not uniform, includes the following:

  • Notice to the patient required prior to dispensing
  • A timeframe for notice that varies from 24 hours up to 10 days
  • Additional labeling requirements and record-retention timeframes
  • Approval by the patient required prior to dispensing
  • State Board of Pharmacy-maintained information required on a website of FDA-approved interchangeable biosimilars
  • No increased liability for a pharmacist who selects an equivalent drug product or interchangeable biological product than incurred by dispensing another drug

Benjamin finished up the presentation by outlining issues and challenges with current state legislation:

  • State laws are not consistent with the BPCIA’s intent, which is to support price competition and innovation in the market, balanced with consumer interests
  • Generally, there is no authority for pharmacists to substitute an interchangeable for the reference product without the intervention of the healthcare provider
  • Generally, there is no recognition of the FDA’s Purple Book, which lists licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations
  • States will probably continue to enact laws that are not consistent with intent of the BPCIA and will likely change the BPCIA definitions and create barriers to dispensing
  • Patient and prescriber confidence in these FDA-approved products may be hindered by restrictive state laws

“It’s essential that we continue to provide patients, pharmacists, prescribers, and decision makers with educational resources to better inform them of the potential for these drugs to provide increased access to safe and more cost-effective drugs,” concluded Benjamin.