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Update on biosimilars: Recent approvals, role for pharmacists

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.

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.

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.”

Pharmacists can educate patients and prescribers on these relatively new pharmaceuticals.

More information about biosimilar can be found on APhA’s resource page, as well as FDA’s website.

Sonya Collins, contributing writer

For the full article, please visit www.pharmacytoday.org for the December 2021 issue of Pharmacy Today. 

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