On 26 August 2013, the California State Assembly voted overwhelmingly in favour of legislation known as SB 598 forbidding a pharmacist from substituting a biosimilar for a brand-name biological if a physician ticks a ‘do not substitute’ box. The bill also requires pharmacists to notify the doctor within five days and sometimes the patient when a substitution is made.

Similar bills have not been enacted in nine other US states [1], and have been condemned by the Generic Pharmaceutical Association (GPhA), which says that such procedures outlined in the proposed bills ‘would create red tape between patients and affordable medicines’ [2].

The board of the California Public Employees’ Retirement System (CalPERS), which manages the largest public pension fund and health benefits to more than 1.6 million public employees and retirees and their families in the US, voted to oppose the measure on the grounds that the language may restrict the ability of consumers to obtain lower cost biosimilars.

The decision could be important for the US, as California is one of the biggest states.

Supporters of such bills on biosimilar substitution argue that they do not prohibit substitution, but rather protect patients. Amgen has also stated that ‘substitution rules that strengthen communication between physician, pharmacist and patient will help accelerate the successful implementation of the US biosimilars pathway’ [3].

The bill, which passed 58-4, will now return to the state Senate, where it was already approved on 2 May 2013, to reconcile changes made in the Assembly.

Related articles
US state biosimilar substitution bill becomes law

Biosimilars bills move on in two US states

References
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
2.  GaBI Online - Generics and Biosimilars Initiative. Fourth US state rejects law restricting biosimilar substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 13]. Available from: www.gabionline.net/Policies-Legislation/Fourth-US-state-rejects-law-restricting-biosimilar-substitution
3.  GaBI Online - Generics and Biosimilars Initiative. Amgen’s response to biosimilar substitution legislation in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 13]. Available from: www.gabionline.net/Biosimilars/News/Amgen-s-response-to-biosimilar-substitution-legislation-in-US

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 © 2013 Pro Pharma Communications International. All Rights Reserved.