Biological products are rapidly increasing in popularity and represent the fastest-growing class of medications in the United States.1 Also known as biologics, the medication’s market size in the US is expected to be valued at over $275 billion by 2030.2 Similar to biologics, biosimilars—which are nearly identical to an original biologic medicine—are quickly gaining traction with no signs of slowing down.
The FDA gave its nod to filgrastim-sndz (Zarxio) in 2015, marking the first time a biosimilar was approved in the US. Since then, the federal agency has gone on to approve a further 45 biosimilars, with each year since that initial date—with the exception of 2020—seeing more approvals than the previous year.3 The country’s biosimilar market is now estimated to reach a total value of $35.1 billion by 2030 as exclusivity ends for more reference products.4
Key Takeaways
- The FDA approved filgrastim-sndz (Zarxio) in 2015, marking the first time a biosimilar was approved in the US. With the exception of 2020, each year since 2015 has seen a rise in biosimilar approvals compared to the year before.
- Despite their increasing availability, biosimilar adoption remains slow. Addressing pharmacist concerns about biosimilars—chief among them being interchangeability—will do much to further their adoption by prescribers and patients.
- It is of critical importance that pharmacists stay updated on the current biosimilar landscape and familiarize themselves with any new products on the horizon to promote biosimilar adoption.
However, despite the significant growth of biosimilars, their adoption across various therapeutic areas has remained slow. Barriers to biosimilar adoption are varied, but the most common ones cited by providers include concerns over safety and efficacy, uncertainties about interchangeability, coverage restrictions that could delay reimbursement, and skepticism over current pricing and expected cost savings.5
As trusted medication experts, pharmacists are key to fostering the adoption of biosimilars and increasing awareness for both providers and patients. But pharmacists themselves are not yet completely comfortable with biosimilars, and gaps in education around the medications are one of the biggest reasons why. A 2022 survey of pharmacists’ knowledge of biosimilars found there was a general lack of understanding and comfortability with key concepts, in particular the topic of interchangeability.6
“Pharmacists, in my opinion, are really the frontline staff,” said Chelsee Jensen, PharmD, BCPS, a senior pharmacy specialist at Mayo Clinic, in Rochester, Minnesota. “We need to make sure that our frontline pharmacy staff has a good understanding of what biosimilars are and their approval pathway so that they are confident when they’re talking to our patients who might be hesitant about a new drug. We want to make sure we can instill as much knowledge and competence in those pharmacists [as we can] so that they can instill that same confidence through their counseling to those patients.”
Biosimilars offer numerous benefits to patients, such as wider availability of treatment options, increased access to biological products, and the potential for lower health care costs. Biosimilars are approximately 30% cheaper on average than their reference products, which resulted in nearly $8 billion of savings for the US health care system in 2020.7 With over 1000 biosimilars in preclinical and clinical development as of 2023,6 strengthening pharmacists’ foundational knowledge about the medications is crucial.
READ MORE: Assessing Pharmacist Attitudes on Biosimilar Dispensing Before, After COVID-19 Pandemic
Addressing pharmacist concerns about biosimilars—chief among them being interchangeability—will do much to further their adoption by prescribers and patients. As far as safety and efficacy are concerned, while minor differences may be present between biosimilars and their reference products, biosimilars are rigorously evaluated by the FDA and have been found to be just as safe and effective.8 Multiple studies in various treatment areas—including oncology, dermatology, and immunology—have been conducted comparing biosimilars with their reference products. A systematic review by Barbier et al that was published in Clinical Pharmacology and Therapeutics found no efficacy, safety, or immunogenicity issues in any of the currently available switching data.9
Interchangeability studies have also shown similar positive results. Interchangeability refers to a biosimilar that can be substituted for an original product, known as pharmacy-level substitution, without consulting the prescriber. These products have gone through additional testing required by the FDA to show that patients who are switched between a reference product and a biosimilar show no increased risks in diminished safety or efficacy.
“Another thing that I think is really important is that just because a biosimilar was granted interchangeability, it doesn’t mean it’s superior or more safe or more efficacious than a noninterchangeable biosimilar,” Jensen said. “All it means is that the manufacturer simply applied for interchangeability and in some cases submitted switching studies. I think that’s a big thing to emphasize to pharmacists as well.”
Jensen also highlighted a few other essential things that pharmacists should understand about biosimilars. Aside from the similar safety and efficacy profiles, pharmacists should be aware of what are known as skinny labels. Skinny labels allow generic drug manufacturers to seek approval for a medicine for a specific use but not other uses patented by the reference product. These labels are FDA approved but serve to delay generic competition for brand-name drug manufacturers.10 “It’s not due to the fact that that drug is not going to be efficacious in that disease state,” Jensen added. “It’s simply because that reference product has a patent protection for that given indication.”
It’s also of critical importance that pharmacists stay updated on the current biosimilar landscape and familiarize themselves with any new products on the horizon. This will give pharmacists the opportunity to be well informed on specific products and which ones may become commonly used in their pharmacy, and help with counseling patients on what will best suit their individual needs. Jensen said that there are plenty of resources pharmacists can use to stay up to speed on the latest data, such as those from the FDA and American Society of Health-System Pharmacists (ASHP).
“I think it’s just really key that our pharmacists understand what resources are out there and the approval pathway,” Jensen said. “Then [they] have that confidence when they’re counseling patients, and they can transfer that confidence to the patient so there’s no nocebo effect.…We don’t want that to happen, and we know that the nocebo effect is something that does occur.”
READ MORE: Biosimilar Resource Center
