Originally published by our sister publication Specialty Pharmacy Continuum
By Heidi Splete
The use of biosimilars can improve patient access and reduce healthcare costs, but understanding some basic concepts about this growing drug class can help optimize those benefits, according to Colin C. Edgerton, MD, a rheumatologist with Articularis Healthcare, in Summerville, S.C.
Different lots of biological products, both reference products and their biosimilars, consist of millions of versions of the same protein, Dr. Edgerton told attendees of the IgNS 2024 National Conference, in Washington, D.C.
Biosimilars have the same mechanism of action as an original reference product, he noted. However, the reference product has been approved through a standard pathway, but biosimilars are approved through an abbreviated process based on how well they compare to the original reference product.
To receive FDA approval, a biosimilar must not only follow the same mechanism of action, but also must have the same conditions of use that were approved for the originator product, with the same route of administration, dosage, form and strength. The manufacturing of biosimilars must meet the same standards as for the reference product for safety, purity and potency, Dr. Edgerton added.
“Biosimilars may be approved based on high similarity to approved reference products, but clinicians may not be convinced of their effectiveness,” he said in the presentation.
However, approved biosimilars may be substituted for the reference product without a healthcare provider’s intervention depending on state laws, Dr. Edgerton noted. The exceptions are the states of Alabama, Indiana, South Carolina and Washington, which do not allow automatic substitution.
You know you are dealing with a biosimilar based on naming conventions, Dr. Edgerton said. Biosimilars combine the nonproprietary core name and a unique four-letter suffix to distinguish them, such as replicamab-cznm.
The benefits of biosimilars include significant healthcare savings, Dr. Edgerton said. Based on current data, biologics account for nearly half (46%) of healthcare spending in the United States, but constitute only 2% of all prescriptions (National Health Expenditures: 2002 Highlights). “Biosimilars generated $9.4 billion in savings in 2023,” he added. Biosimilars have contributed to reduced spending in traditional drug classes including treatments for diabetes, respiratory, cardiovascular and mental health, with a share of net spending shift from 72% in 2011 to 45% in 2021, and similar trends in specialty classes, he said (2022 U.S. Generic and Biosimilar Medicine Savings Report).
In Dr. Edgerton’s area, rheumatology, biosimilars have demonstrated reductions in cost and are expected to improve patient access to medications. In the case of brand-name Remicade and infliximab, for example, the average sales price decreased from nearly $800 in the first quarter of 2019 to approximately $400 in the fourth quarter of 2022 (IQVIA National Sales Perspective Smart Data; September 2023).
Still, challenges to the wider use of biosimilars remain, including formulary access, clinician concerns about multiple drug switches, patient reports of name confusion and nocebo effects, and issues with prior authorization, Dr. Edgerton noted. Insufficient reimbursement from the Centers for Medicare & Medicaid Services also has the potential to limit access to biosimilars, he added.
Nevertheless, the pipeline for biosimilar products remains robust for rheumatology and other specialties, Dr. Edgerton noted, adding that clinicians should feel confident pursuing these alternatives for their patients.
Dr. Edgerton reported no relevant financial disclosures.