Kareem Karara, PharmD, BCPS, CCHP: The 2019 study by Bruno Emond and colleagues showed that patients who switched from originator to biosimilar infliximab were 3½ times more likely to switch to another biological originator or discontinue index treatment than those who remained on the originator biological. Patients who switched from the parent drug to the biosimilar were more likely to switch therapy than those who left their therapy alone. There have been other studies before and after this 2019 study that identified this phenomenon.
In addition to the research provided, there have been others. This is an increasingly well-documented line of research. Many of these studies evaluate patients switching from the innovator product to a biosimilar. The likelihood of patients discontinuing treatment or switching to another biologic innovator is well documented, but the reasons for discontinuation and switching are unknown. The resistance of physicians and patients to switching from biologics is one of the major barriers to their adoption, especially the adoption of biosimilars, despite the cost savings that can be achieved through the use of biosimilar therapies. Even if there are indications that switching is safe, resistance can occur among doctors and patients. For example, the 2018 NOR-SWITCH study, which switched infliximab biosimilars in patients with inflammatory bowel disease, showed no increase in disease activity.
One area I look forward to monitoring is the impact of pharmacists’ involvement in switching from biosimilars. There was a presentation at the ASHP meeting in 2022 that suggested that pharmacists can have a meaningful impact on ensuring patients stay on one formulation of their biologic product, be it a biosimilar or the original product. The authors suggest that the integration of pharmacists into these clinic spaces will be an important cost-effective tool in increasing the comfort of healthcare providers with biosimilars.
Improving access and availability of biologics, including the generic biologics, holds promise to improve the quality of care for patients. This is because biologics are the most expensive prescription drugs in the United States. This poses significant barriers to patients’ access to what are increasingly becoming necessary treatments. The original policy goal of the biosimilar approval process was to reduce healthcare costs for these products and improve access. However, the overall market penetration of the biosimilars that have entered the market to date has been limited. Given their low usage, they have not achieved the original goal policymakers had in mind of increasing competition and lowering prices. Unbranded biologics provide another way to bring low-cost biologics to the market, with the ultimate goal of improving patient access.
Transcription edited for clarity.