Delaware passes biosimilars substitution law

Home/Policies & Legislation | 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


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
Panama embraces international pharmacovigilance standards
Pharmacovigilance V13F21
Home/Policies & Legislation Posted 09/07/2024
FDA proposal to remove biosimilar interchangeability status in FY25
01 AA007239
Home/Policies & Legislation Posted 12/06/2024
MHRA unveils strategy for regulating AI technologies
23 AA011020
Home/Policies & Legislation Posted 22/05/2024
Regulatory Certainty Strategy for biosimilars launched in Mexico
Home/Policies & Legislation Posted 09/04/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010