Blog Big Molecule Watch July 06, 2022

Amgen releases preview of 2022 biosimilars report

Amgen recently released a preview of its 2022 Trends in Biosimilars Report, which includes an analysis of the trends in US biosimilar launches and approvals; a timeline of biosimilar approvals and launch dates; trends in pricing, uptake, and total drug spend; and considerations for the future of biosimilars.  According to Amgen, the “US marketplace is poised to see growth in biosimilar approvals, similar to pre-pandemic rates, spurring additional competition that will potentially lead to significant savings for the healthcare system, which can then be deployed to newer, innovative treatments.”  Since the first U.S. biosimilar approval in 2015, a total of 36 biosimilars have been approved in the United States.  21 of those biosimilars have commercially launched in the United States.

According to Amgen, biosimilars help “reduce healthcare costs by providing significant wholesale acquisition cost (WAC) and average sales price (ASP) savings at launch and through price competition,” noting that the ASP of both reference products and biosimilars have continued a “steady downward trend” with decreasing compound annual growth rates of 4% to 22% and 9% to 22%, respectively.  This is bolstered by the increasing rate of biosimilar uptake, with an average share of 74% for therapeutic areas with biosimilars launched in the last 3 years.  Biosimilar competition appears to contribute to decreased drug spending, as the cumulative savings in drug spend for classes with biosimilar competition is estimated to have been $18 billion over the past 6 years.  The estimated decrease in drug spend trends towards quarterly increases, with an estimated $3 billion savings in drug spend in Q1 2022 alone.

Amgen predicts that changes, such as the approval of interchangeable biosimilars, biosimilars in more therapeutic areas, and expansion of biosimilars into pharmacy benefit reimbursement programs, will “cement the role of biosimilars as viable and integral US treatment options.”

The full report has an anticipated release in Q3 2022.

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