Report: Biosimilar Uptake Accelerates in US—and So Do the Savings

Use of biosimilars by US physicians is picking up steam, and the marketplace “is poised to growth” in both approvals and uptake after hiccups caused in part by the pandemic, accordingto a recent industry overview from Amgen.

The 2022 “Trends in Biosimilars Report Preview,” which offers highlights of the biosimilars marketplace ahead of a full report to come this fall, said health care savings from the use of these biologic therapies climbed to $3 billion in the second quarter of 2022, for total of $18 billion over the past 6 years.

Ongoing success of biosimilars is a team effort. “Essential components of provider and patient use of biosimilars include payer coverage as well as addressing the clinical, operational, and economic considerations to help support adoption,” the report notes. With biosimilars poised to remake new therapeutic areas, “provider and pharmacist education will be critical.”

Savings is important, but it’s not the only consideration: payers and physicians alike want to know that manufacturers are producing high-quality drugs and that supply chains are reliable.

US Pace Faster Than Europe at Same Stage

US biosimilar activity hit a peak in 2019 with 10 approvals and 7 launches, but things slowed the next 2 years, in part because regulators’ attention turned toward responding the COVID-19 pandemic. There were 4 US approvals and 2 launches in 2021, and there have been 3 approvals thus far in 2022. However, the Amgen report authors note that there were 97 products in the FDA Biosimilar Development Program in December 2021, up from 77 in March 2019, offering a sign of what’s to come.

The United States did not approve its first biosimilar until 2015, almost a decade after the first product was approved in Europe (2006). Although the European Union (EU) has had quite a head start, the report’s authors note that in year 8, the EU had approved 15 biosimilars, and “by contrast, in the 8 years after the US approved the first biosimilar, there were 36 approvals.”

The authors assert that the rate of biosimilar uptake is increasing and that once these biologics become part of the scene in a therapeutic area, they gain market significant market share. Prior to 2019, the average market share for therapeutic areas with biosimilars was 38%, but today that has climbed to 74%.

Of note, being first matters. “First-to-launch biosimilars tend to capture a greater portion of the segment compared to later entrants,” they write.

Competition With Humira: Waiting on the Game Changer

Thus far, uptake and acceptance of biosimilars has been greater in oncology than in rheutmatology, but that could all change after January 31, 2023. That’s when biosimilars will arrive for Humira (adalimumab), which generated more than $20 billion in sales in 2021.

The prospect of 7 or more adalimumab biosimilar launches in 2023 could lead to reduced spending across multiple autoimmune conditions for which Humira is indicated. “Based on the history of pricing for biosimilar and reference products seen in other areas, the entry of additional biosimilars is expected to lead to greater price declines across all products within the class,” the report states.

What’s next? Amgen’s report predicts that approvals for biosimilars in the US marketplace will move beyond the areas of oncology, autoimmune disease, and endocrinology. A greater focus on education—from providers, to pharmacists, to patients—will lead to new discussions at the pharmacy counter, especially as more interchangeable biosimilars are approved. “These changes are likely to cement the role of biosimilars as viable and integral US treatment options.”