1. State of Biosimilars Legislation
Elisabeth Brisley, MPH
Academy of Managed Care Pharmacy
Alexandria, VA

2. Biosimilars and Interchangeable Drug Products Legislation and LawsAK
45 states and PR have laws that address biosimilar and interchangeable drug products
9 states passed legislation in the 2018 session – Alaska, CT, Michigan, NH, SD, VT, WV, Wisconsin, & Wyoming
2019 anticipate that the following states (2) will introduce legislation: Maine and Arkansas – Maine did pass the first law which is a mini version of “creates” which requires sharing of originator samples with biosimilar manufacturers

3. Timeline of State Legislation
Delaware, Florida, Indiana, Massachusetts, North Dakota, Oregon, Utah and Virginia passed the first set of biosimilars legislation.
Arizona, California, Colorado, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Minnesota, Missouri, New Jersey, North Carolina, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Washington passed legislation.
2017
Iowa, Kansas, Maryland, Minnesota, Montana, Nebraska, Nevada, New Mexico, New York, Ohio and South Carolina passed legislation.
2018
Alaska, Connecticut, Michigan, New Hampshire, South Dakota, Vermont, West Virginia, Wisconsin and Wyoming were the latest states to pass legislation

4. State Activity on Biosimilars and Interchangeables
Began legislating in 2013 before any applications for biosimilar approval were filed in the U.S. – first one not approved until March 2015
Most states do not recognize interchangeable products as defined by the BPCIA may be substituted by pharmacist without intervention of the provider
Requires electronic communication not all pharmacies/prescribers linked in EHR – and won’t be for a while – other means require more pharmacist time
Added requirements could impact prescriber/patient confidence in the products and slow and/or stop market uptake of biosimilars
References to the Orange Book, instead of the Purple Book designated by FDA, as the resource for biosimilarity and interchangeability evaluations
BPCIA – Biologics Price Competition and Innovation Act of 2009
any regulations on the approval of biosimilars or interchangeables, the states have been actively attempting to regulate substitution of these products.
Prescriber must designate “dispense as written” or “brand medically necessary”
Pharmacy must notify/communicate to prescriber of substitution via fax, telephone, electronic health record, or medication history function of electronic prescribing system
Pharmacy must include additional information on label.
Pharmacy must provide patient consent before dispensing
Pharmacy must retain records of substitution in pharmacy management system for longer time period than for other drugs dispensed
Board of pharmacy must maintain a list of interchangeable products on website.