Indiana biosimilars substitution bill becomes law

INICIO/Políticas y legislación | Posted 28/03/2014 post-comment0 Post your comment

Indiana Governor Mike Pence signed into law on 25 March 2014 legislation that will allow pharmacists to substitute biosimilars that the US Federal Drug Administration (FDA) has approved as interchangeable with an originator biological under certain conditions.

Senate Bill 262 (SB 262) allows substitution by the pharmacist if the prescribing physician has not indicated on the prescription that a substitution is not permitted. The law also requires that the pharmacist inform the patient of the substitution and notifies the physician, in writing or electronically, within 10 days of the substitution. The pharmacy and the prescribing physician must also retain a written or electronic record of the biosimilar substitution for at least two years.

The Biotechnology Industry Organization (BIO), Indiana Health Industry Forum (IHIF) and the Alliance for Safe Biologic Medicines (ASBM) have all come out in support of the legislation. BIO stated that the bill ‘preserves patient access to accurate prescription information, maintains incentives for innovation and promotes a competitive market for biologic[al] therapies’. Whilst the IHIF stated that the legislation maintains ‘proper communication between pharmacists and prescribing physicians’.

The Generic Pharmaceutical Association (GPhA) has, on the other hand, previously stated that any laws concerning biosimilar substitution are ‘premature and unnecessary at this time’, given that FDA is yet to issue final guidance or receive a biosimilars application [1]. The GPhA also believes that legislation like this – requiring notification and record-keeping – ‘slows patient access to biosimilars’.

Generics maker Hospira, however, ‘expressed its gratitude’ at the signing into law of SB 262, saying that the law ‘creates a pathway for the substitution of interchangeable biologic[al] drugs and helps pave the way for patient access to cost savings from biosimilar products’. Hospira added that the company is preparing to bring biosimilars to patients in Indiana and across the US as soon as 2015.

Editor’s comment
Readers interested to learn more about US state legislation on biosimilars substitution are invited to visit to view the following manuscript published in GaBI Journal:

US state legislation on biosimilars substitution

If you are interested in contributing a research paper in a similar area to GaBI Journal, please send us your submission here

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US state biosimilar substitution bill becomes law

Biosimilars bills move on in two US states


1.   GaBI Online - Generics and Biosimilars Initiative. US state legislation on biosimilars substitution []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 28]. Available from:

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Source: ASBM, BIO, GPhA, Hospira, Indiana Governor

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