Colorado, which rejected a similar bill in 2013, is the latest state trying to prepare for an influx of biosimilars in the US. Earlier this year, a panel of FDA experts recommended approval for the first biosimilar to hit American shelves.
If approved, Colorado’s law would mirror a host of others from Florida, North Dakota, Oregon, Utah, Virginia and Indiana, which has created a patchwork of state substitution laws, many of which add notification requirements for pharmacists looking to dispense what may be cheaper alternatives to costly biotech drugs.
Colorado’s bipartisan bill, introduced by two Republicans and two Democrats, would specifically require pharmacists “within a reasonable amount of time” to “communicate to the prescribing practitioner the specific biological product dispensed to the patient, including the name of the product and manufacturer, through an electronic system.”
A possible point of contention in the bill is that it only allows a pharmacist “to substitute a biological product if the federal food and drug administration (FDA) has determined that the biological product is interchangeable with the prescribed biological product and if the practitioner has not indicated that the prescription must be dispensed as written.” The FDA has yet to issue any guidance on how it will determine interchangeability for biosimilars.
The bill also requires that state pharmacies from which an interchangeable biologic is dispensed “must retain a record of the substitution for at least 2 years; and the pharmacist substituting an interchangeable biological product for a prescribed biological product must notify the purchaser orally and in writing and may only substitute a biological product if the substituted product costs less than the prescribed biological product, unless the prescribed biological product is not in stock and the purchaser consents to the higher-priced product.”
The bill also mandates that the state board of pharmacy maintain a link on its website to the FDA resource that identifies biological products approved as interchangeable.
The bill is similar to a bill that died in a state Senate committee in 2013 after both advocates and proponents of the bill weighed in a fierce debate over whether the notifications were necessary. Biologics heavyweight Amgen and the Colorado BioScience Association originally backed the 2013 bill, while generics company Sandoz said the notifications would be unnecessary. In November, Amgen filed a lawsuit seeking more information on how Sandoz would manufacture its biosimilars.
Amgen spokeswoman Kelley Davenport told us that Amgen supports the new bill and has been working alongside Sandoz and other biosimilar developers on consensus legislation in various states.
"Over the past 2 years, we’ve worked with other biologic manufacturers, including biosimilar developers, and other stakeholders to reach a consensus that leverages health information technology, where available, to achieve shared access to dispensing information for both prescribers and pharmacists. Pharmacist-physician communications will foster confidence in all biological medicines, including originator products, biosimilars, and interchangeable biologics," Amgen said in a statement.
Similarly, some opponents of the patchwork of state legislation have said the legislation may hinder the adoption of biosimilars, while others say the legislation is necessary to ensure the adoption of biosimilars in the US proceeds safely.