The cumulative savings from biosimilars have been $ 9.8 billion over the past 5 years and over $ 2 billion in the second quarter of 2021, according to the Amgen 2021 Biosimilar Trends Report, which was published in its in full this week.
These savings come mainly from the products trastuzumab and bevacizumab, used for a range of oncology treatments; infliximab, for autoimmune diseases; and pegfilgrastim, used to treat chemotherapy-related neutropenia, according to Amgen.
The report presents an optimistic outlook for 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 says.
It notes that in the second quarter of 2021, the FDA listed 90 proposed biosimilars that were on the agency’s biosimilar development program, up nearly 60% from October 2015, when the first US biosimilar (Zarxio , filgrastim) has been approved.
The report predicts the integration of biosimilars into drug benefit management plans, biosimilars available for a wider range of therapeutic areas and the 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 treatment options in the United States,” the report says.
“Some of the best-selling biologics are expected to have biosimilar competition in the coming years, such as Lucentis (ranibizumab), Humira (adalimumab), Stelara (ustekinumab), Cimzia (certolizumab pegol) and Prolia / Xgeva (denosumab)”, states The report.
Biosimilars for autoimmune diseases have perhaps the greatest savings potential for the American public. The report notes that Humira had $ 20.4 billion in revenue in 2020, largely through the use of healthcare in the United States. There are 6 approved adalimumab biosimilars, and there could be 8 in total when they start making their debut in the U.S. market in 2023, Amgen says.
In the European Union, competition from adalimumab biosimilars has successfully reduced Humira’s volume sales by 59% since January 2018, Amgen said. The best-selling biosimilar adalimumab in the European Union is Amgevita (Amgen), with a 20% market share. It is closely followed by Hyrimoz (Sandoz) and Imraldi (Samsung Bioepis / Biogen), with 17% and 16% respectively.
“Providers are increasingly familiar with prescribing biosimilars; however, there is still work to be done, ”the report says. Amgen cited a recent survey of 602 specialists who regularly prescribe biologics. Results 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 adopt biosimilars, which could help promote competition and potentially reduce costs to the US healthcare system,” the report says. Additionally, value-based policies that incorporate biosimilars have the potential to lower costs for employers, he says.
The report discusses biosimilar policies at the federal level and concludes: “US policymakers can better nurture a long-term sustainable market for biosimilars by maintaining effective policies that allow direct competition between reference products and between biosimilars. “
Amgen concludes with a list of 4 policy elements that the company believes are necessary to support the growth of the biosimilars market:
- “Scientifically Appropriate” Regulatory Standards
- A market that encourages competition on an equal footing
- A science-based educational program to support confidence in the use of biosimilars among healthcare providers, patients, payers and employers
- Strong intellectual property protections to drive innovation and investment among manufacturers of biopharmaceuticals.
The Biosimilars Center® covered further details of the report released in July.