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New Tool Helps Providers Navigate Adalimumab Biosimilars
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The tool consolidates and highlights key features that would be considered when choosing a biosimilar adalimumab.
The first biosimilar approved in the United States was for filgrastim in 2015. The flood gates opened for adalimumab biosimilars in 2023 when the patent for Humira expired, although adalimumab biosimilars have been available in Europe since 2018.1 The wave of new agents continues to swell, with no signs of slowing. This growth represents opportunities as well as challenges to both providers and patients, impacting their receptiveness and application to treatment plans.
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Like the dawn of traditional generics for small molecules, health care professionals need to not only educate themselves regarding biosimilars but are also relied upon to confidently reassure patients. According to researchers Giavatto et al, just 16% of prescribers and 13.4% of pharmacists feel “very prepared” to discuss biosimilar options with patients.2
A biosimilar is defined as an FDA-approved biopharmaceutical that is similar but not identical to its original biologic, also known as the reference or originator product.3 It should be manufactured from the same type of source, provide the same benefits when treating medical conditions given at the same strength and dosage, and should not be expected to cause new or worsening adverse effects. Biosimilars are differentiated with 4 letters following the nonproprietary name following the FDA’s drafted guidance in “Nonproprietary Naming of Biological Products.”3 Biosimilars may be granted an additional FDA-approved interchangeable label if they meet additional regulatory requirements, outlined by the Biologics Price Competition and Innovation Act of 2009, and provide established data to support switching back and forth from the reference product without greater risks.4
As of March 4, 2024, there are 48 FDA-approved biosimilars, of which 10 are approved for adalimumab. Of those, only 3 have been approved as an interchangeable (Abrilada, Cyltezo, and Simlandi).5 State laws pertaining to substitution and prescriber notification vary.
When prescribing or filling adalimumab prescriptions, health care providers are beginning to receive more denials from pharmacy benefit managers (PBMs) as their formularies are modified, resulting in confusion and uncertainty.6 Providers must also consider their institutional formularies, patient preferences, and supporting data. In addition to journal articles detailing the studies, package inserts and product websites, the FDA’s Purple Book and the NIH’s Dailymed are resources for choosing the optimal biosimilar product. However, navigating these to compare products may be cumbersome, particularly with diverse insurance coverage populations. These decision-making factors may potentially contribute to delays in continuing patient treatment plan if not familiarized with the products.
There is a need for a practical and visually appealing tool that has relative, succinct, and up to date information. To fill this need, our team designed a chart7-28 to consolidate and highlight key features that would be considered when choosing an adalimumab biosimilar. It compares bullet points for ease of comparison and for optimal education of staff to provide resources to patients.
It may be a helpful guide for pharmacists who participate with their institution’s formulary preferences after evaluating costs. In particular, this resource may be most useful for pharmacists and nurses or biologic coordinators to efficiently and effectively counsel patients and caregivers, whether they are naïve to therapy or are switching from another biosimilar brand. For example, if a payor mandates Cyltezo, which is only available in the original formulation, patients switching from Humira would need to be counseled that the volume is twice as much as they are accustomed to. Similarly, Hyrimoz uses the Sensoready technology where there is no “button” to push, and patients may need counseling on proper administration.
Payors may ultimately dictate which biosimilar a patient receives, but if given a choice, a quick reference chart will aid pharmacists in making sound recommendations. Optimal features for patient compliance and adherence are high concentration formulation (HCF), citrate free for less injection site pain/burning, autoinjector device option, nursing support, copay card, safe sharps programs, and accessible injection videos. The ability to conveniently access key specifications for comparison to the reference product is invaluable for patient care, especially as more biosimilars enter the marketplace.
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