DOSE OF REALITY: BIOSIMILAR SLOWDOWN UNDERSCORES URGENCY FOR SOLUTIONS TO FOSTER GREATER COMPETITION, ENCOURAGE BIOSIMILAR DEVELOPMENT

Sep 16, 2026

Congress Should Pass Bipartisan, Market-Based Solutions to Reduce Unnecessary Friction for Biosimilars, Crack Down on Big Pharma’s Patent Abuse That Extends Biologic Monopolies

In case you missed it, new reporting from Axios highlights growing concerns about a slowdown in biosimilar development and the potential consequences for patients and the U.S. health care system, underscoring the urgency for bipartisan, market-based solutions that would support greater biosimilar competition and foster more investment into developing these more affordable alternatives to high-priced brand name biologic drugs.

Axios notes that while several high-priced brand name biologic drugs are expected to lose patent protection over the next decade, industry estimates show biosimilar alternatives are currently in development for only about one in ten of those products.

The report also points to new data from the Association for Accessible Medicines (AAM) that warns a continued slowdown in biosimilar development could mean billions of dollars in unrealized savings for patients and the broader health care system.

The Axios report underscores what the data has long shown: greater biosimilar competition effectively lowers prescription drug costs for patients, taxpayers and the U.S. health care system. Biosimilars are more affordable alternatives to complex, high-priced brand name biologic drugs, and greater competition can place downward pressure on the price of the brand name products they compete with.

A closer look at the data shows the significant savings greater biosimilar competition can deliver:

Out Of Pocket Costs For Biosimilars 23 Percent Lower Than Reference Biologics: A March 2024 JAMA Network study found that average patient out-of-pocket costs for biosimilars in the commercial market were 23 percent lower than their reference biologics, or roughly $200 less on average.

Generic And Biosimilar Savings In 2025: $496 Billion: A September 2026 Association for Accessible Medicines report found that generics and biosimilars generated $445 billion in savings for patients and the U.S. health care system in 2023 and $3.1 trillion in savings over the previous decade.

Projected Savings Of Greater Biosimilar Competition Between 2021 And 2025: $38.4 Billion: A July 2022 American Journal of Managed Care (AJMC) analysis found that greater biosimilar competition and uptake could generate $38.4 billion in savings for the U.S. health care system between 2021 and 2025, with much of those savings driven by downward pressure on the prices of competing brand name biologics.

Biosimilar List Prices Are 15 To 35 Percent Lower Than Branded Biologics: According to a July 2021 U.S. Food and Drug Administration (FDA) press release, biosimilars launched in the U.S. typically have initial list prices 15 to 35 percent lower than their reference products.

Despite the significant savings greater competition can deliver, Big Pharma continues to game the system to block and delay more affordable alternatives from reaching patients, while unnecessary regulatory barriers can further discourage biosimilar development and slow market entry.

Congress must capitalize on growing bipartisan momentum for market-based solutions to lower prescription drug prices by fostering greater competition. In July, the U.S. House Committee on Energy and Commerce advanced the Biosimilar Red Tape Elimination Act (H.R. 5526) and the Expedited Access to Biosimilars Act (H.R. 9661), while the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) advanced the Expedited Access to Biosimilars Act (S. 1414).

The Biosimilar Red Tape Elimination Act (S.1954/H.R. 5526) would eliminate outdated U.S. Food and Drug Administration (FDA) requirements and modernize the drug approval process to expedite biosimilar substitution and increase competition from more affordable alternatives to high-priced brand name products.

The Expedited Access to Biosimilars Act (S.1414/H.R. 9661) would eliminate costly, duplicative clinical testing requirements and modernize the FDA review process to reduce unnecessary delays, foster greater biosimilar competition and bring more affordable alternatives to high-priced brand name biologic drugs to market faster.

Lawmakers should build on the bipartisan work to advance these solutions and swiftly pass them into law.