Biosimilars
Sonya Collins
This year has seen the approval of 2 new biosimilar drugs, including the first biosimilar to earn FDA’s “interchangeable” designation. Byooviz (ranibizumab-nuna) is biosimilar to Lucentis (ranibizumab), a drug for neovascular (wet) age-related macular degeneration (nAMD). Semglee (insulin glargine-yfgn), the first such drug to earn the “interchangeable” distinction, is biosimilar to Lantus (insulin glargine) for diabetes.
These are the latest of 31 FDA-approved biosimilar drugs proven in clinical trials to have no clinically meaningful differences when compared to the reference drug. Greater uptake of these medications could lower health care costs for payers and potentially for patients. Pharmacists can educate patients and prescribers on these relatively new pharmaceuticals.
Two new biosimilars hit the market
Byooviz is the first biosimilar to Lucentis (ranibizumab), an injectable monoclonal antibody for nAMD, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.
Drugmakers win FDA approval of biosimilars like Byooviz when they show that there is no “clinically meaningful difference” between their drug and the reference drug. In the absence of meaningful differences, FDA relies on the safety and efficacy data already generated for the reference drug and thereby streamline the approval process for the biosimilar.
Semglee underwent a more rigorous approval process to gain an interchangeable designation with the reference biologic Lantus, a long-acting insulin analog.
“Interchangeable approval requires a more complex trial design, in which there are at least 3 or 4 arms,” said R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA, director of the Phase I Clinical Trials Program at Emory Winship Cancer Institute in Atlanta, GA. “In one arm, patients are started on the reference and then switched over. In another, they’re started on the biosimilar and then switched to the reference. In another, you only get the reference or you only get the biosimilar.”
Pharmacists in many states may have the authority to substitute biologics with interchangeable biosimilars just as they would substitute branded medications with generics.
In a statement, FDA expressed hopes that the interchangeable biologic would increase access and potentially lower costs for people who depend on daily insulin.
Making the switch
Because biosimilars have no clinically meaningful difference from the reference drug, Harvey said “switching over would be the expected natural process of having a new drug available at a reduced cost.”
But surveys show that prescribers may be reluctant to switch. A report published by the University of Chicago’s NORC found that a vast majority of prescribers believed biosimilars are as safe and effective as the reference drugs. However, while half of polled prescribers were willing to start a patient on a biosimilar, fewer than a third felt comfortable switching a patient who was already doing well on the reference biologic.
A 2020 review in Advances in Therapy concluded that overall data on switching, including switching between multiple biosimilars as well as switching back to the reference drug, are sparse. The reviewers underscored a need for additional robust, well-designed, long-term studies on the effects of switching.
“We’re still fairly early on, and that ‘early-on’ mentality doesn’t allow us to have a ton of confidence. The studies weren’t done to change patients midstream,” Harvey said. “But I think we can have confidence that there would be no difference in the vast majority of patients if they were switched midstream.”
A role for pharmacists
If pharmacists have patients who have trouble paying for their biologic drugs, they can explore whether a biosimilar might save that patient money and can contact the patient’s prescriber about switching.
“It takes some time, but I would applaud any pharmacist who takes those steps and tries to advocate for patients to make sure they stay on therapies that we expect to be as effective as a reference product,” Harvey said.
When patients pick up a prescription for a biosimilar for the first time after a prescriber has ordered a switch, they may have concerns.
“Pharmacists should have an understanding of the process of development and approval for biosimilars so they can explain it to patients in layperson’s terms and give them confidence in that medication,” Harvey said. “Anything you can do to explain why patients should have confidence that this drug is just as effective goes a long way toward helping individuals have confidence in their therapy and their caregivers from pharmacists to prescribers and everybody in between.”
Resources
APhA has created an FAQ document to help members and their patients navigate the rapidly evolving biologic and biosimilar landscape.
Pharmacists must understand the distinctions between conventional medications, biologic medications, biosimilars, and their interchangeability; their journey to the marketplace; and the regulations that affect how they are dispensed. Most importantly, pharmacists must be prepared to educate patients on the appropriate use of these products.
Access the biosimilar infographic on the following page and more resources at www.pharmacist.com/Advocacy/Issues/Biosimilars