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

Biosimilars and Interchangeable Drug Products Legislation and Laws AK 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

Timeline of State Legislation 2013-2014 Delaware, Florida, Indiana, Massachusetts, North Dakota, Oregon, Utah and Virginia passed the first set of biosimilars legislation. 2015-2016 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

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.