Arizona passes pharmacy biosimilar law

June 2, 2016

Arizona recently joined around 20 other states by passing a law allowing pharmacists to substitute certain interchangeable biosimilar drugs for brand name drugs.

Arizona has joined around 20 other states by passing a law allowing pharmacists to substitute certain interchangeable biosimilar drugs for brand name drugs.

As of December 31, 2016, Arizona pharmacists can substitute FDA-approved interchangeable biosimilars in place of an originator biologic, as long as the physician has not instructed the pharmacist to "dispense as written." 

Editor's Choice:Below-costs Rxs: One state just says noHouse Bill 2310  (the Substitution of Interchangeable Biologic Medicines) was generally supported by pharmacists, but the Arizona Pharmacists Association expressed concerns about the bill's reporting requirements, especially for small, independent pharmacies.

Kelly Fine"The opposition comes with adding unnecessary documentation and reporting requirements that are not consistent with current generic substitution laws or in accordance with current FDA guidance documents. Pharmacists do not want additional burdens on workflow when we already have a system in place that has worked for over 30 years with generic drugs," said Kelly Fine, RPh, CEO of the Arizona Pharmacy Association.

Fine said revised language in the bill addresses "most of these concerns and deems entering the prescriptions into an electronic system or PBM system would satisfy the notification requirements."

Opponents of the bill were also concerned that some biosimilars are not exactly the same as the brand name, so the side effects of those medications are unknown. "When the [biosimilar] drug goes through the approval process, the FDA is going to look at how close they are. If a biologic treatment is so close, the FDA will have the opportunity to determine if the drug is an interchangeable biosimilar, [not simply a biosimilar]," said Joan Koerber-Walker, president and CEO of Arizona BioIndustry Association.

 

The Arizona law, and many other state laws that have been passed, requires pharmacists to notify patients' physicians when they substitute a biosimilar drug for a branded drug. "If a patient were to respond differently [to the biosimilar drug], the doctor would need to know what changed," Koerber-Walker said.

However, the same requirement is not in place if the pharmacist substitutes for an FDA-approved interchangeable biosimilar, because the two drugs are identical.

Koerber-Walker said while some physicians would like to know about the biosimilar substitution in advance, or to be able to make the substitution decision themselves,  a "reasonable compromise" had to be made.

"One thing everybody was in agreement on was that it had to be the best solution for the patient," she said. "If the pharmacist had to go back to the physician to get permission first, then that sick patient is stuck at the pharmacy while the process is going on."