Biosimilar Switching: Don't ask. Don't tell.

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  • 02/03/2014

Witness the support of the GPhA to Florida’s pending legislation on biosimilars.

FDA News reports that, GPhA has jumped into the biosimilars substitution debate, saying it prefers that doctors not be notified when a pharmacist substitutes a biosimilar for a name-brand biologic, and it is supporting legislative language that would implement that approach in states throughout the U.S.

GPhA and other critics believe the physician notification provisions of the compromise will deter pharmacists from making substitutions.

Making sure that a patient gets the best treatment should never be viewed as "impeding access." That's a canard and shows the venality of a certain approach to biosimilars. 

This bill should be called "The Biosimilars Don't Ask, Don't Tell Act."  Rather than placing the burden of knowledge on physicians and pharmacists, this bill forces a patient  (often a very ill patient) to demonstrate an advanced level of pharmaceutical sophistication. Is it plausible that patients are educated enough to know what a biosimilar is, let alone ask whether or not they are getting a biologic or a biosimilar? This is clearly not the case with small molecule generics – a much less complicated proposition. The fact that physicians have the ability to use "prescribe as directed" is good. But it is not enough.

A more practical Washington State bill offers a better, holistic and appropriate approach, specifically the language that reads:

If a biological product is dispensed, the pharmacist or the pharmacist's designee shall within a reasonable time but not to exceed ten days following the dispensing, record the name and manufacturer of the product dispensed in an interoperable health records system shared with the prescribing practitioner, to the extent such a system is available; or, in the case that an interoperable electronic health records system is not in place, communicate to the prescribing practitioner the name and the manufacturer of the biological product dispensed to the patient. No communication to the prescribing practitioner is required under this subsection where there is no interchangeable biological product for the prescribed biological product, or for a refill prescription that is not changed from the product originally dispensed.

This makes it much better legislation than the Florida version and a superior piece of "model legislation."


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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