Delaware passes biosimilars substitution law

INICIO/Políticas y legislación | Posted 25/04/2014 post-comment0 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.

Substitution V13F14

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].

Related articles

Indiana biosimilars substitution bill becomes law

California governor vetoes biosimilars bill

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2014 Pro Pharma Communications International. All Rights Reserved.

Source: BIO,Delaware State Senate

comment icon Comments (0)
Post your comment
Related content
Consulta pública para la modificación de la regulación de biosimilares
02 AA010638
INICIO/Políticas y legislación Posted 16/01/2024
COFEPRIS promueve la cooperación regulatoria en América
Latin America 1638px
INICIO/Políticas y legislación Posted 12/12/2023
Pendiente la decisión de ANVISA sobre las ‘skinny labels’ para genéricos
Labelling V14I26
INICIO/Políticas y legislación Posted 14/11/2023
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010