California Assembly passes biosimilars substitution bill

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California has taken a step closer to adopting legislation which would authorize pharmacists to substitute an FDA-approved biosimilars for their reference biologicals with a notification to prescriber within five days.

Regulation V13H16

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

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 []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 13]. Available from:
3.  GaBI Online - Generics and Biosimilars Initiative. Amgen’s response to biosimilar substitution legislation in US []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 13]. Available from:

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