At least 7 biosimilars for adalimumab (Humira–AbbVie, Inc.) are expected to hit the market in 2023. Pharmacists may find themselves managing patients on these new prescription drugs, encouraging physicians to switch their patients, or motivating patients themselves to accept these new options.
“Pharmacists play an extremely valuable role in biosimilars—in communications about these drugs with both physicians and patients,” said Ryan Haumschild, PharmD, director of pharmaceutical services at Emory University Hospital Midtown in Atlanta, GA. “Pharmacy needs to come up with standardized language to use around all biosimilars, not just Humira.”
Ten individual biosimilars
Amgen's Amjevita (adalimumab-atto), which earned FDA approval in 2016, is expected to enter the market in January 2023. By the following July, up to 9 other biosimilars may join it.
While Humira has indications that span rheumatology, dermatology, gastroenterology, and ophthalmology, not all of its biosimilars will be indicated for all the same conditions.
The 10 biosimilars also differ from one another in their interchangeability designations. So far, only Cyltezo (adalimumab-adbm) has earned the designation. Hadlima (adalimumab-bwwd) is expected to have the designation after its launch. Applications for 2 others are currently under review.
Regardless of interchangeability, in general, patients should notice little to no difference between reference drugs and their biosimilar counterparts.
“We can rely on the data we've seen on other biosimilars to feel confident they will have appropriate disease control,” Haumschild said. “For the most part, patients make the transition between agents pretty seamlessly.”
As for other differences among the 10 biosimilars, there are low- and high-concentration options as well as citrate-free and citrate formulations.
“It's important for pharmacists to familiarize themselves with the differences when these biosimilars reach the market so they can be more informed when they are counseling patients and when they are recommending these therapies to physicians,” said Haumschild.
Counseling patients, educating prescribers
Patients who have their chronic conditions well controlled on Humira may be hesitant to switch to a biosimilar. Pharmacists might be in a position to recommend this switch to the patient or prescriber. Or, in some cases, the switch may be triggered automatically when payers will no longer cover the reference drug. In this case, the patient might learn for the first time that their prescription has changed when they pick it up at the pharmacy.
On the other hand, prescribers may write prescriptions with the footnote “Dispense as written” or “Brand medically necessary.” Sometimes this is because the patient has expressed concerns about switching and the provider doesn't want to force the patient.
In any of these cases, pharmacists may need to counsel patients or educate prescribers on biosimilars and their relationship to the reference drug.
“We've seen time and again that switching does not cause any significant increase in immunogenicity or any exaggeration of disease,” Haumschild said. “We can explain the similarities, the similar efficacy, and the highly similar product profile that was approved by the FDA.”
When applicable, pharmacists might also point out to patients or prescribers that the switch to a biosimilar will save the patient money. This may not always be the case; however, as sometimes PBMs choose to cover the reference drug exclusively.
“Anytime we recognize financial toxicity, we should feel comfortable reaching out to the provider if it will benefit the patient,” Haumschild said.
Overall, biosimilars deliver very “similar” results to the reference drugs. Besides potential cost-savings, biosimilars bring patients more options, which always yields advantages. More options can open up additional patient assistance programs. It can also offer alternatives in the face of shortages.
These are all talking points pharmacists can emphasize in conversations with patients and prescribers.
“When we are able to engage the patient, we can decrease their fear of starting the medication and help ensure better uptake and compliance, which will hopefully lead to better outcomes,” said Haumschild.
APhA offers a pharmacist's guide to patient's frequently asked questions about biologics and biosimilars. Visit apha.us/BiosimilarsFAQ for more information.