Late Last month, the FDA approved the fourth biological product—a biosimilar version of the rheumatoid arthritis (RA) drug Humira named Amjevita. Given the scientific complexity surrounding the origin and definition of biosimilars, pharmacists—one of the most trusted healthcare professionals—will likely play a key role in widespread adoption of this and other biosimilars to follow.
As described in this issue in the article titled, “Biosimilars: Current Approvals and Pipeline Agents,” by Kiran Panesar, original, or reference, biologics are a large component of the healthcare delivery continuum in the United States. Though currently constituting less than 1% of all prescriptions dispensed, Ms. Panesar writes, biologics nonetheless make up 28% of prescription-drug spending, and their numbers are projected to increase more than 20% per year. By 2025, in fact, biologics could account for close to three-quarters of New Drug Approvals, she adds.
A biological product designated as a biosimilar is highly similar to the reference product, allowing for minor differences in the clinically inactive component while not showing clinically meaningful differences in safety, purity, and potency. Unlike generic medications, biosimilars—unless they are so similar they are deemed interchangeable—cannot be automatically substituted for branded medications. Pharmacists must intervene to persuade the physician and patient alike to switch to the less costly, nonbranded biosimilar alternative.
To be designated as interchangeable, a biosimilar product can be expected to produce the same clinical result as the reference product in any given patient, and, for a biologic that is administered more than once, the risk of alternating or switching between use of the biosimilar product and the reference product is not greater than the risk of maintaining the patient on the reference medication.
Based on recent clinical research, pharmacists have plenty of ammunition to make the case for biosimilars and interchangeables. An article published recently in Annals of Internal Medicine reports that generic forms of a biologic—tumor necrosis factor–alpha inhibitors used to treat RA, inflammatory bowel disease, and psoriasis—appear to be as safe and effective as their brand-name counterparts. Even when manufactured by different companies, medications made from living cells can be equivalent, according to collected data from 19 studies conducted through April.
Lending more credence to this emerging medication class, the Generic Pharmaceutical Association created the Biosimilars Council, charged with working to ensure a positive regulatory, reimbursement, political, and policy environment for patient access to biosimilar medications while educating the public and patients about biosimilar safety and effectiveness.
And further portending the likely growth of biosimilars is the appearance of the first Purple Book. A compilation of biological products and their corresponding biosimilar names, it will serve as the biopharmaceutical equivalent of, and function in much the same way as, the Orange Book for generic medications.
In addition to advocacy by trusted pharmacists, the way biosimilars are identified could affect acceptance among prescribers and patients. According to a recent report in the Journal of Managed Care & Specialty Pharmacy based on a survey by Daniel Tomaszewski, PharmD, PhD, of Chapman University in Irvine, California, confidence levels in a substituted biosimilar are highest when products share the same nonproprietary moniker as the reference biologic. The naming convention, the survey suggests, could even impact pharmacists’ inclination to recommend switching to a biosimilar or dispensing an interchangeable biologic.
As Ms. Panesar writes, pharmacist-reported adverse events could contribute to the accelerated postmarketing data environment of biosimilars. And pharmacists can convey useful efficacy and safety feedback about biosimilars, putting physicians and patients more at ease about changing from a branded innovator product.
Well-informed pharmacists will build confidence in patients whenever discussions about biosimilars arise, promoting access to more economical treatment options.
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