In the Florida House, the Health Quality Subcommittee approved a bill on 19 February 2013 creating standards for using biosimilars.

The House Bill 365 sponsored by House Representative Matt Hudson, provides a mechanism that would allow pharmacists to substitute a biosimilar for a brand-name drug in a manner similar to one now used to dispense generic drugs. It would, however, require the pharmacist to notify the prescribing physician within five days of the substitution and require the physician and pharmacist to maintain a record of the substitution for at least four years.

Meanwhile, in the Colorado House a similar bill was passed by an overwhelming 10–1 majority.

House Bill 1121 sponsored by House Representatives Sue Schafer and Carole Murray allows for substitution of biosimilars for brand-name biological drugs if the pharmacist notifies the patient orally and in writing, notifies the prescribing physician of the switch and keeps a record of the switch for five years. Senator Irene Aguilar, Chairwoman of the Senate Health and Human Services Committee, has said, however, that the bill ‘may have a harder time making it through her chamber’. The Senator is concerned that the bill ‘will discourage pharmacists from suggesting a biosimilar substitution, thereby doing nothing to lower the cost of health care’.

These bills are just a few of several bills in statehouses across the US that are seeking to enable the first biosimilars to come onto the market in the US within two years.

The bills would only allow biosimilar substitution if cumbersome conditions were met by physicians and pharmacists. Generics makers, pharmacists and pharmacy benefit managers, on the other hand, support automatic substitution of biosimilars deemed interchangeable with their brand-name biological and have called the legislation premature, given the fact that FDA is yet to issue final guidelines for the biosimilar approval process.

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

Editor’s comment
Please feel free to share your thoughts via email or in the comments section below. Is such legislation trying to limit biosimilar substitution in the US? Or will these bills really just ensure patient safety?

Related article

FDA finally issues draft biosimilar guidance

References

1.  GaBI Online - Generics and Biosimilars Initiative. US FDA defends biosimilar substitution [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 15]. Available from: www.gabionline.net/Biosimilars/General/US-FDA-defends-biosimilar-substitution

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