Institute Report
Biosimilars in the United States 2020–2024
Competition, Savings, and Sustainability
Sep 29, 2020

About the Report

The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 provided a regulatory pathway for biosimilar products in the United States. Though savings from biosimilars had been slow to build, recently-launched biosimilars have achieved significant uptake within their first year, and the availability and use of biosimilar medicines is on track to reduce drug costs by $100 billion over the next five years. The development and approvals of biosimilars have been accelerating over the past two years, bringing a total of 33 approvals across 13 molecules to date. Details on biosimilar availability and use are presented in this report, along with scenarios for future biosimilar sales and the systemic savings that they may generate in the future.

Report Summary

This report assesses the current state of the biologics market in the United States and finds that the development and approvals of biosimilars have been accelerating. There have been 33 approvals across 13 molecules to date, though biosimilars for two molecules have not yet launched, and 108 additional biosimilars are in development across 22 other molecules. Savings enabled by the presence of biosimilars are modeled to exceed $100 billion in aggregate over the next five years, though volume and price dynamics remain volatile and significant uncertainty remains.

The current biologics market of $211 billion can be segmented into 19% of the market, or $40 billion, already facing some biosimilar competition, 64% or $135 billion potentially open to biosimilar competition, and an additional 17% of the market, or $36 billion, unlikely to ever face biosimilar competitors. Among recent biosimilar launches, bevacizumab, trastuzumab, and rituximab are set to reach nearly 60% share of volume for their respective molecules by the end of their second year on the market — showing significantly higher and faster uptake than prior biosimilars. This reflects efforts by providers to capture available savings, although their adoption has been highly heterogenous, while patients have benefitted from biosimilars in the form of lower out-of-pocket costs. The introduction of biosimilars in some cases has generated 2–4% incremental demand for the molecule. Finally, the report finds that large pharma companies, often with existing innovative biologic portfolios, have dominated the marketing of biosimilars to date, while smaller companies are developing biosimilars but are more likely to license products to a larger company for marketing.

Key Findings

The availability and use of biosimilars have accelerated and are on track to reduce drug costs by $100 billion over the next five years.

Estimated Savings from Biosimilars at Invoice Prices
  • Sales of biosimilars over the next five years could total $80 billion, depending on volume uptake and pricing discounts.
  • Since the passage of the Biosimilars Act (BPCIA), $17 billion of biosimilar spending has been associated with savings of $37 billion.
  • The next five years are expected to result in an almost five-fold increase in savings relative to the past five years, as newly approved biosimilars launch and existing biosimilars see continued uptake and price reductions.



The three most recent biosimilar launches are set to reach nearly 60% shares of volume by the end of their second year on the market — significantly higher and faster than prior biosimilars.

Biosimilar Share of Volume Since Biosimilar Launch, DDDs
  • The three most recently launched biosimilars in 2019 have achieved significant uptake within their first year: bevacizumab (42%), trastuzumab (38%), and rituximab (20%).
  • These biosimilars are trending towards almost 60% by the end of two years on the market — substantially higher than prior biosimilars and similar to the high rates of adoption in Europe.
  • Bevacizumab biosimilars achieved substantially higher share in outlets not eligible for 340B discounts, which may be the result of a strategic approach by biosimilar companies to prioritize contracting with those outlets.



Absolute savings from biosimilars vary, with larger savings from more recent launches where originators were more costly.

Originator and Mean Biosimilar Average Sales Price (ASP) in US$, July 2020
  • Patients who typically pay 20% of Medicare Part B costs are benefiting from average sales price (ASP) reductions of $500–$1900 for a standard course of treatment of the three most recent biosimilars launched.
  • Medicare and commercial patients save an average of $17 per prescription when using a biosimilar insulin, with Medicare paying on average $18–19 and commercial patients paying $13–14.
  • For pharmacy products, average invoice prices are often closest to the price patients pay during their deductible, notwithstanding pharmacy mark-ups.



Development of biosimilars is being driven by smaller companies, while marketing is done mostly by large companies.

Biosimilars in Development and Marketed in the United States by Company Type and Size
  • Currently, 13% of biosimilar products in development are being developed by six large pharma companies.
  • The remaining 87% are being developed by 41 smaller companies with varying degrees of biologic or biosimilar development experience.
  • Of biosimilar products marketed in the United States, 14 were developed and launched by seven large pharma companies.
Institute Research Brief
A positive road ahead for biosimilars?
The trajectory of biosimilars has changed – and according to current projections, will continue on an upward path. With continued increases in biologics spending expected, the biosimilars market presents an opportunity for savings on medicines.
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