Biosimilars: Leveraging Real World Evidence to Drive Patient Access

Updated on July 23, 2023
Confident professional doctors examining a patient's x-ray and woman on wheelchair helped by a nurse on the background

This is a landmark year for the biosimilars market, as the first biosimilars for the $20-billion-a-year blockbuster Humira (adalimumab) enter the United States market. The debut of several lower-cost versions of adalimumab with demonstrated efficacy, safety and quality has many in the health care industry talking about the potential for increased market competition to significantly reduce health care costs. 

The potential for biosimilars to lower overall health care spending can’t be overstated. Pricey biologic medicines have accounted for 37% of total prescription drug spend in the United States in recent years, even though they make up only 2% of total prescription volume, according to research by RAND Corporation. The potential savings from low-cost alternatives are vast: In a 2022 report, RAND projected that in the five years ending in 2025, the U.S. health care system will save an estimated $38.4 billion on biologics due to the market entry of new biosimilar drugs. The savings could actually be much higher – as much as $124.5 billion – if the uptake of biosimilars meets the most optimistic projections, the RAND researchers said.

To fully realize the economic potential biosimilars offer, we must overcome some hurdles standing in the way of widespread adoption. One major challenge is that many patients view biosimilars as generic drugs, or worse, cheap knockoffs.Given that branded biologic medicines have transformed the treatment of many complex and debilitating conditions – including cancer, multiple sclerosis, Crohn’s disease and ulcerative colitis – patients who have responded well to those treatments are understandably nervous about switching away from them. 

There is even some resistance to biosimilars in the provider community. According to a recent report from Cardinal Health, 36% of rheumatologists are concerned about the efficacy of biosimilars, and 24% aren’t convinced they offer much in the way of economic benefits. 

A lack of familiarity with biosimilars contributes to these hesitancies. To overcome the skepticism, the industry needs to provide more real-world evidence demonstrating the efficacy and safety of switching from reference products to biosimilars, as well as switching between biosimilars. Furthermore, providers and payers should leverage the data that already exists to educate patients about the clinical benefits biosimilars offer. 

Several studies have proven that biosimilar drugs can be as efficacious and safe as originator medicines. For example, a 2021 study of 271 patients with inflammatory bowel disease (IBD) led by University of Pennsylvania researchers found that 81% of patients who were in remission and switched from branded infliximab (Remicade) to a biosimilar remained in remission. Patients who made a “double” switch, meaning they moved from one biosimilar to another, experienced similar clinical outcomes to those who only made one switch.

A retrospective cohort study published earlier this year described results of patients with Crohn’s disease and ulcerative colitis who were treated at a Veterans Affairs facility and switched from the infliximab originator drug to a biosimilar. The researchers found that there were no significant differences in adverse events among patients who switched to biosimilars vs. those who stayed on the branded medicine, leading them to conclude that biosimilar switching is safe and effective

Expanding the use of biosimilars will drive more than just economic benefits – it will benefit patient care, as well. Under the best-case scenario for biosimilar adoption, the money saved on prescription drug spending could be poured into innovative methods for optimizing the use of biologics in patient care. For example, some studies have shown that monitoring biomarkers, antibodies and pharmacokinetics in patients who are taking biologics can help physicians design personalized dosing regimens, which can further drive optimal care.

To make that vision a reality, the biosimilars industry needs to better communicate to patients, payers and providers through real-world evidence that these affordable medications are as effective as their pricier predecessors. Addressing the clinical barriers and knowledge gaps surrounding biosimilars will increase market access and help the health care system realize all of the benefits these low-cost medicines can bring to patients.

Tom Nusbickel is Chief Commercial Officer of Celltrion USA
Tom Nusbickel

Tom Nusbickel is Chief Commercial Officer of Celltrion USA.