In Cardinal Health’s 2023 Biosimilars Report, more than 60% of surveyed providers said they would only want to prescribe adalimumab biosimilars with interchangeability designations, suggesting the label may have a greater impact on uptake than originally expected.
Over 60% of providers, including rheumatologists, gastroenterologists, and dermatologists, surveyed as part of Cardinal Health’s 2023 Biosimilars Report for adalimumab biosimilars, said that they would only feel comfortable prescribing adalimumab biosimilars that have interchangeability designations.
This could signal that providers view interchangeability designations to be significant identifiers about the safety or safety of switching to a particular biosimilars. In the past, experts have argued that interchangeability in the United States doesn’t hold much value in establishing switching safety because the United States is the only country to have such a designation.
Overall, about 84% of providers reported feeling “very comfortable” or “somewhat comfortable” with prescribing a biosimilar referencing Humira (adalimumab) to their patients, with gastroenterologists having the highest comfort level (93%).
However, among the surveyed dermatologists, 66% said that they “strongly agree” or “agree” with the statement “I will only feel comfortable prescribing an adalimumab biosimilar if it has the interchangeability designation." Similarly, 62% of rheumatologists and 64% of gastroenterologists said they “agree” or “strongly agree” with the statement.
Currently, only 1 adalimumab biosimilar (Cyltezo) has the designation and 4 others (Hadlima, Abrilada, AVT02, and Yuflyma) are expected to receive interchangeability status prior to or post launch. Overall, there are 4 interchangeable biosimilars (Cyltezo, Cimerli, Basaglar, and Rezvoglar), only 2 of which have entered the market (Cimerli and Basaglar), neither of which have obtained significant uptake so far.
Regulatory agencies in the European Union and the United Kingdom have published statements declaring all biosimilars to be interchangeable with their reference products, and a majority of jurisdictions in Canada have implemented switching policies to phase out reference products in favor of biosimilars from the market. For European countries and Canadian jurisdictions that have experience with biosimilar switching, clinical outcomes have not been compromised as a result. For reference, the European Union has 10 adalimumab biosimilars on the market and Canada has 9.
A big concern surrounding the designation is that interchangeable biosimilars may be viewed as superior to biosimilars that do not have interchangeability designation. However, interchangeable biosimilars are not better or safer than any other biosimilars for the same originator, and the designation is simply an indicator that a biosimilar can be swapped in for a reference product at a pharmacy without requiring physician permission.
In addition to interchangeability, most dermatologists and gastroenterologists reported that device and ease of use (72% and 69%, respectively) will be “very important” for them when considering prescribing an adalimumab biosimilar. A majority of rheumatologists (62%) will also be looking for citrate-free adalimumab options.
The top concern regarding adalimumab biosimilars was safety and efficacy, with 70% of dermatologists, 64% of rheumatologists, and 33% of gastroenterologists listing this as a main concern. Cost savings for patients, safety of switching from Humira to a biosimilar, payer and pharmacy benefit manager coverage, and the existence of clinical and/or real-world evidence were also reported as key concerns or decision criteria for utilization of an adalimumab biosimilar.
“As we conclude this preview, one thing is for certain: In, 2023 all eyes are on adalimumab and its deep slate of incoming biosimilars. We believe the impacts from this [loss of exclusivity] will likely be felt differently depending on the stakeholder group in question, but there is no doubt the evolution of competition in this market will have far reaching implications for the entire U.S. healthcare industry,” wrote the authors of the report.