Indiana Governor Signs Biosimilar Substitution Bill

by McDonnell Boehnen Hulbert & Berghoff LLP
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IndianaOn March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain conditions are met.  Senate Bill 262, which was authored by Sen. Brandt Hershman (R) and Ronald Grooms (R) and co-Authored by Sen. Jean Breaux (D), was passed by the Indiana Senate in January by a 38-11 vote and by the Indiana House in February by a 92-5 vote before the bill was signed by Governor Pence.

The legislation will allow a pharmacist to substitute a biosimilar product for a prescribed biological product if five conditions are met: (1) the biosimilar product has been determined by the U.S. Food and Drug Administration to be interchangeable with the prescribed biological product, (2) the practitioner prescribing the biological product has included the instruction "May substitute" on the prescription, (3) the pharmacist has informed the customer of the substitution, (4) the pharmacist notifies the practitioner within five days of the substitution, and (5) the pharmacy and practitioner retain a record of the interchangeable biosimilar substitution for at least five years.  The legislation enacted in Indiana is very similar to the California bill that Governor Jerry Brown vetoed last fall as being "premature" because the FDA had not determined the standards required for biosimilars to meet the higher threshold for interchangeability (see "Governor Brown Vetoes California Biosimilar Bill").

In the Indiana legislation, biological products are defined as including viruses, therapeutic serums, toxins, antitoxins, vaccines, blood, blood components, blood derivatives, allergenic products, proteins (except any chemically synthesized polypeptides), products analogous to the above products, arsphenamine, arsphenamine derivatives, or any other trivalent organic arsenic compound, wherein the product is applicable to the prevention, treatment, or cure of a disease or condition for human beings.  Biosimilars are defined in the bill, in part, as being licensed as such under 41 U.S.C. § 262(k) (which appears to be a typographical error as the section on the "Licensure of biological products as biosimilar or interchangeable" appears in Title 42).  Finally, the legislation defines "interchangeable" as meaning that the FDA has determined that a given biosimilar product may be substituted for a reference biological product without the intervention of the healthcare provider that prescribed the biological product.

In a statement issued last month, the Biotechnology Industry Organization (BIO) and Indiana Health Industry Forum (IHIF) commended Governor Pence for signing Senate Bill 262, and called the bill "a model for legislation necessary in all 50 states to address this cutting-edge technology."  BIO noted that it would "continue to advocate for full transparency in the substitution process as patients and their physicians should have the right to know what biologic medicine the patient receives from the pharmacy."

Flag map of Indiana by Wapcaplet, from the Wikipedia Commons under the Creative Commons Attribution-Share Alike 3.0 Unported license.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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