Delaware passes biosimilars substitution law

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Delaware passes biosimilars substitution law

INICIO/Políticas y legislación | Posted 25/04/2014 0 Post your comment

Delaware has become the latest US state to pass a law allowing substitution of a biosimilar for an originator biological, but with certain restrictions.

The Delaware State Senate passed Senate Bill 118 (DE SB118) by a unanimous vote (21 to 0) on 9 April 2014.

The bill allows pharmacists to substitute US Food and Drug Administration (FDA) approved interchangeable biosimilars for prescribed biological reference products if the prescribing physician has not expressly prohibited substitution. The law also requires that the pharmacist records information on the label and dispensation record, informs the patient of the substitution and notifies the physician, in writing or electronically, within 10 days of the substitution. The pharmacy must also maintain a written or electronic record of any such substitutions for three years.

The Biotechnology Industry Organization (BIO), which represents originator biologicals companies, and the non-profit trade association Delaware BioScience Association (Delaware Bio) issued a statement in support of the legislation. The groups agree that the bill ‘ensures transparency and communication between patients and their treatment teams’ and ‘includes transparent communication on all biologic[al] medicines dispensed in order to maintain a consistent and complete medical record’.

The Generic Pharmaceutical Association (GPhA) has pointed out, however, that such laws are in conflict with the Biologics Price Competition and Innovation (BPCI) Act of 2009, which FDA ‘expressly states that an interchangeable biological product may be substituted for the reference product without the intervention of the healthcare provider’. Given the fact that FDA is yet to issue final guidance or receive a biosimilars application, GPhA also believes that laws concerning biosimilar substitution are ‘premature and unnecessary at this time’ [1].

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Reference

1. Derbyshire M. US state legislation on biosimilars substitution. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(3):155-6. doi:10.5639/gabij.2013.0203.040

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Source: BIO,Delaware State Senate