Survey: US Pharmacists Have Homework to Do on Biosimilar Interchangeability

Pharmacists have limited awareness of concepts underlying FDA approval of the interchangeable designation for biosimilars, according to survey findings presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2021 meeting.

Just 20% correctly answered that based on FDA approval of interchangeable status, a pharmacist can substitute a biosimilar for a reference drug without consulting with the prescribing physician.

Slightly more than half (53%) correctly answered that it is “appropriate for a pharmacist to dispense an interchangeable biosimilar in place of its reference product without authorization from the prescriber if consistent with state law.”

Community pharmacists (50%) were less likely to answer this question correctly than those in other practice settings (54%-61%).

“Additional and focused educational strategies for US pharmacists are required to bridge these gaps and increase confidence in dispensing biosimilars,” authors of the study concluded.

States do have ultimate say in allowing biosimilars to be used interchangeably, although the FDA is the granting authority when it comes to approving biosimilars as interchangeable with their reference products. There are 2 approved interchangeable biosimilars: Semglee (insulin glargine) and Cyltezo (adalimumab). Only Semglee is on the market currently.

All states have passed laws governing how interchangeable biosimilars may be dispensed. Cardinal Health has documented these in an extensive state-by-state user guide.

The survey was conducted in March 2021, prior to when the first US interchangeable biosimilar was approved (July 2021), and pharmacist respondents were relatively unaware that no biosimilars had been designated as interchangeable when they answered the questionnaire. Just 11% answered correctly that all of 12 biosimilars on a list were not interchangeable. “Awareness was slightly higher among managed care pharmacists in other practice settings,” the authors wrote.

In the survey findings, which were presented at the AMCP Nexus 2021 meeting, investigators described the increasing relevance of biosimilars and interchangeable biosimilars to the practice of pharmacy.

“The potential to deliver cost savings may increase patient access to biologic therapies and help control overall health care costs,” they wrote.

In conducting the survey, they sought to plug gaps in available quantitative data on US pharmacists’ attitudes toward and understanding of biosimilars. Investigators derived their data from 500 survey forms (curated from 992 individual responses) representative of the Northeast, South, Midwest, and West.

The survey consisted of 36 questions that assessed biosimilar knowledge and understanding from FDA approval to state pharmacy law and patient involvement.

Investigators said 81% of respondents correctly answered that a biosimilar approved for all the same indications of the reference product is not automatically interchangeable with that product.

Hospital or health system pharmacists got this question right (71%) less often than those in other practice settings (81%-96%), and investigators said it was probably because the general use of “therapeutic equivalence” in health care systems can be confusing.

They said 83% correctly responded that an interchangeable biosimilar is not the same thing as a generic drug.

A higher percentage (86%) correctly answered that switching studies are required for a biosimilar to demonstrate interchangeability and involve multiple switches from reference drug to biosimilar.

They said 16% answered incorrectly that all biosimilars are approved as being interchangeable.

Most pharmacists answered correctly (87%) that noninterchangeable biosimilars are as safe and effective as interchangeable biosimilars.

Just 51% of pharmacists said they were at least moderately comfortable answering patients’ questions about biosimilars, and 29% said they were “somewhat” comfortable.

Just 36% of pharmacists said they always or mostly involve patients in decisions about starting therapy with a biosimilar and switching to a biosimilar, whereas 32% said they “sometimes” do.

Investigators said 66% of the respondents worked in a community setting. The remainder were evenly split among home care or home infusion settings, ambulatory or outpatient centers, or specialty pharmacy and hospital/health system environments. A smaller percentage, 5%, worked in a managed care setting.

Investigators said 32% had practiced pharmacy for more than 20 years and 37% for 10 years or fewer.

“The majority of respondents correctly stated that a biosimilar has equivalent efficacy (87%) and comparable safety (91%) to its reference product,” they wrote.

The pharmacists were better versed in state laws on pharmacy and “correctly answered further questions on state pharmacy laws and biosimilar substitution,” the report said.

Reference

Stevenson JG, McCabe D, McGrath M, McBride A. A survey to assess pharmacists’ knowledge and understanding of biosimilars and interchangeability. Poster presented at: AMCP Nexus 2021; October 18-21, 2021.