Kareem Kalala, PhD, BCPS, CCHP: In a 2019 study by Bruno Emond et al., patients who switched from brand-name to biosimilar infliximab were more likely to switch to another brand-name biologic or follow an index treatment than those who remained on the brand-name biologic. They were shown to be 3.5 times more likely to discontinue. Patients who switched from a brand-name drug to a biosimilar were more likely to change treatment than those who remained on treatment. did.
In addition to the studies provided, there were others. This is an increasingly well-documented series of investigations. Many of these studies evaluated patients switching from a brand-name product to a biosimilar. It is well documented that these patients are likely to discontinue treatment or switch to another originator formulation, but the reasons for discontinuation and switching are unknown. Despite the cost savings, physician and patient resistance to biopharmaceutical switching remains one of the major barriers to biopharmaceutical adoption, especially biosimilars. Even when there is evidence that switching is safe, physician-patient resistance may arise. For example, the 2018 NOR-SWITCH trial switched infliximab biosimilars among patients with inflammatory bowel disease and found no increase in disease activity.
One area I look forward to monitoring is the impact of pharmacist involvement in biosimilar switching. In a presentation at his ASHP conference in 2022, the pharmacist will discuss meaningful ways to ensure that a patient stays on her one prescription of a biologic, whether it is a biosimilar or a brand-name product. suggested that it can influence The authors suggest that the integration of pharmacists into these clinic spaces will be an important cost-saving tool in increasing the comfort of healthcare providers with biosimilars.
Improving access and availability to biologics, including unbranded biologics, offers the potential to improve the quality of patient care. This is because biologics are the most expensive prescription drugs in the United States. This poses a significant barrier to patient access to increasingly needed treatments. The original policy goal of the biosimilars approval pathway was to reduce healthcare costs and improve access to these products. However, overall market penetration has been limited among biosimilars that have entered the market to date. Low utilization has prevented policy makers from achieving their initial goals of increasing competition and lowering prices. Off-brand biologics offer another avenue to bring low-cost biologics to market, with the ultimate goal of improving patient access.
Edited transcript for clarity.