Amgen Estimates $9.8 Billion in Cumulative US Biosimilar Savings

Cumulative savings from biosimilars was $9.8 billion over the past 5 years and more than $2 billion in the second quarter of 2021, according to the Amgen 2021 Biosimilar Trends Report, which was released in full this week.

Those savings derived mainly from trastuzumab and bevacizumab products, used for a range of oncologic treatments; infliximab, for autoimmune diseases; and pegfilgrastim, used to treat chemotherapy-related neutropenia, according to Amgen.

The report presents an upbeat outlook on the development and availability of biosimilars in the near future. “We expect growth in the number of biosimilars, both in terms of breadth and depth,” the report states.

It notes that in the second quarter of 2021, the FDA listed 90 proposed biosimilars that were enrolled in the agency’s Biosimilar Development Program, up nearly 60% from October 2015, when the first US biosimilar (Zarxio, filgrastim) was approved.

The report predicts integration of biosimilars into pharmacy benefit management plans, biosimilars available for a wider range of therapeutic areas, and approval of more interchangeable biosimilars. The first interchangeable biosimilar (Semglee, insulin glargine) was approved in July 2021.

“These changes are likely to cement the role of biosimilars as viable and integral US treatment options,” the report states.

“Some of the best-selling biologics are expected to have biosimilar competition in the next few years, such as Lucentis (ranibizumab), Humira (adalimumab), Stelara (ustekinumab), Cimzia (certolizumab pegol), and Prolia/Xgeva (denosumab),” the report states.

Adalimumab Biosimilars

Biosimilars for autoimmune diseases have perhaps the greatest potential to bring savings to the American public. The report notes that Humira had sales of $20.4 billion in 2020, largely from US health care use. There are 6 approved adalimumab biosimilars, and there could be 8 in total when they start to debut on the US market in 2023, Amgen says.

In the European Union, competition from adalimumab biosimilars has succeeded in lowering sales by volume of Humira by 59% since January of 2018, Amgen said. The best-selling biosimilar adalimumab in the European Union is Amgevita (Amgen), with a 20% market share. This is followed close behind by Hyrimoz (Sandoz) and Imraldi (Samsung Bioepis/Biogen), with 17% and 16% shares, respectively.

“Providers are becoming increasingly familiar with prescribing biosimilars; however, there remains work to be done,” the report states. Amgen cited a recent survey of 602 specialists who prescribe biologics regularly. The findings indicated that 39% were comfortable using a biosimilar to treat a patient and 55% were very comfortable prescribing biosimilars.

“Increasingly, payers are showing a desire to embrace biosimilars, which could help to promote competition and potentially lower costs for the US health care system,” the report states. Further, value-based policies that incorporate biosimilars have the potential to lower costs for employers, it says.

The report discusses biosimilar policies at the federal level and concludes, “US policymakers can best nurture a long-term, sustainable marketplace with biosimilars by maintaining effective policies that allow head-to-head competition among reference products and between biosimilars.”

Amgen concludes with a list of 4 policy elements the company says are necessary for sustaining growth of the biosimilars market:

• “Scientifically appropriate” regulatory standards
• A marketplace that encourages competition on a level playing field
• A science-based educational program to support confidence in the use of biosimilars among health care providers, patients, payers, and employers
• Strong intellectual property protections to stimulate innovation and investment among biopharmaceutical makers.

The Center for Biosimilars^® covered other details from the report that were released in July.