Two bills (HB 2326 and SB 6091) from the Washington State House and Senate concern the prescription of biological products. They are the first legislative effort of their kind to be endorsed by a coalition of biologicals and biosimilars manufacturing companies.

The legislation includes transparent communication on all biological medicines dispensed in order to maintain a consistent and complete medical record. According to BIO, this will ensure transparency and communication between patients and their treatment teams, and is fully consistent with the BIO principles.

BIO’s principles include the safeguards that: the patient, or the patient’s authorized representative, should, at a minimum, be notified of the substitution of biological products; and that the pharmacist and the physician should keep records of the substitution. These two principles are particularly relevant to the treatment of chronic disease, where patients may have tried multiple regimens to find the safest, most effective therapy and where a disease evolves over time so accurate records must be kept.

In 2012, the US Food and Drug Administration (FDA) issued guidance on developing biosimilar products and is currently developing a pathway for the development and approval of safe and effective interchangeable biological products. It is vital that individual states, such as Washington, play a role in supporting transparent substitution practices and keeping physicians engaged in the process.

FDA defends the substitution of interchangeable biosimilars, with FDA Commissioner Margaret Hamburg saying in 2013 that attempts to undermine trust in biosimilars are ‘worrisome and represent a disservice to patients who could benefit from these lower-cost treatments [1].

Related articles

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Biosimilars bills move on in two US states

US FDA defends biosimilar substitution

Biotech firms try to limit biosimilar substitution in US

Reference

1.  GaBI Online - Generics and Biosimilars Initiative. US state legislation on biosimilars substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 7]. Available from: www.gabionline.net/Policies-Legislation/US-state-legislation-on-biosimilars-substitution

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