Biosimilars, an Untapped Revolution

Authored by: Tom Rainey, Senior Vice President, U.S. Biosimilars at Teva

Fact: branded biologic drugs are consistently among the most expensive in our healthcare system.¹ Compounding this, chronic conditions – often treated with biologics – are becoming increasingly prevalent, presenting an immense challenge and untenable burden on patients and providers alike. The status quo is simply unsustainable.

But there’s a clear path forward – biosimilars. A newer class of drugs, that are highly similar, lower-cost versions of complex biologic drugs that have no clinically meaningful differences from their original, patented counterparts. This is about more than options, it’s about restoring affordability, expanding access and delivering genuine hope to patients. What’s more, the market growth potential for biosimilars is expected to increase to $121 billion globally by 2033.²

Let’s talk about a healthcare revolution hiding in plain sight. Since the first biosimilar approval in the U.S. in 2015, biosimilars have delivered a staggering $36 billion in savings to our strained healthcare system.³ And that number could grow to $180 billion in savings by 2028, but we have to embrace widespread adoption.⁴

My entire career has been dedicated to the evolving pharmaceutical landscape. And for more than a decade at Teva, I’ve been a part of the strategic preparation for this pivotal moment with biosimilars. With the second largest biosimilars portfolio in the industry, we are not just merely recognizing the positive impact that biosimilars could have on the healthcare ecosystem, we are actively building the future of affordable access.

But that future is not quite here yet. Because despite the undeniable power of biosimilars, we face significant hurdles, especially when you consider that biologics alone represent a whopping 45% of the total drug expenditure in the U.S.⁴ It is absolutely critical that we dismantle every factor impeding biosimilar adoption—the health of patients and the solvency of our system depend on it.

A Biosimilar Void

Biosimilars have had a significant impact on improving U.S. health outcomes by treating various medical conditions and providing millions of patients with care they otherwise may not have received if a biosimilar option was not available. However, rising biologic drug prices with no affordable alternative biosimilar options is forcing some patients to delay or forego needed medications, worsening their acute and chronic health conditions.⁵

Additionally, the rate of patent expiries is accelerating for biologics. Industry analyses confirm that an average of 12 biologics will lose patent protection annually between 2025 and 2034.⁶ And yet only 12 of the 118 biologics expected to lose exclusivity in the next decade have biosimilars in active development, leaving approximately 90% without potential competition.³ There is a huge opportunity here for companies like Teva who understand the importance of biosimilars – and their impact on patient affordability.

Pushing for an Integrated Ecosystem to Encourage Utilization

The U.S. continues to experience slower adoption driven by payer and pharmacy benefit manager (PBM) coverage decisions, provider reimbursement issues and regulatory challenges. The new draft guidance by the FDA may address the latter barrier as it looks to reduce clinical testing burdens for biosimilars and to treat them more like generics, something we know a lot about at Teva. While policy initiatives, like the Inflation Reduction Act, have the potential to bolster the utilization of biosimilars, the timelines stipulated in the law do not provide sufficient opportunity for biosimilars to enter the market before the negotiated prices are in place.

Because of this, the environment for healthy competition and a sustainable biosimilars marketplace is negatively impacted, directly disrupting greater patient access to affordable medicines. It is crucial that we push for adjusted drug pricing policies that ensure biosimilar competition is encouraged rather than punished. A fully competitive biosimilar market could save the U.S. an additional $189 billion over the next decade. ³

Making Biosimilars a Priority

To truly unlock the monumental potential of the U.S. biosimilar market, we need experienced leaders in the industry who are not only committed but proven to drive change. For decades, Teva has been a relentless champion of affordable medicine. And with the industry’s second largest biosimilars portfolio, we have made it a priority to offer competitively priced, easily accessible biosimilars in the U.S.⁷ Teva is best positioned for this exact moment, leveraging our proven commercial capability alongside clinical and regulatory expertise stemming from our broad portfolio and heritage within innovative, generic and biosimilar medicines.

The time for decisive action is now.

To learn more about biosimilars visit TevaBiosimilars.com.

References:

1. Department of Health and Human Services: Office of Inspector General. (2024). Biosimilar Cost and Use Trends in Medicare Part B. https://oig.hhs.gov/documents/evaluation/9811/OEI-05-22-00141.pdf.
2. GlobeNewswire. Biosimilars market size is projected to reach USD 121.88 billion by 2033, growing at a CAGR of 15.56%. Published January 23, 2025. https://www.globenewswire.com/news-release/2025/01/23/3014367/0/en/Biosimilars-Market-Size-is-Projected-to-Reach-USD-121-88-Billion-by-2033-Growing-at-a-CAGR-of-15-56-Straits-Research.html.
3. Biosimilars Council. (2024, January). The biosimilar void: A crisis in patient access and a call to action. https://biosimilarscouncil.org/resource/the-biosimilar-void-a-crisis-in-patient-access-and-a-call-to-action/
4. IQVIA Healthcare Information Technology and Pharma Clinical Research Company. Biosimilars in the United States 2023-2027. (2023, January). https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/biosimilars-in-the-united-states-2023-2027.
5. U.S. Department of Health and Human Services. (n.d.). Fact sheet: Bringing lower-cost biosimilar drugs to American patients. FACT SHEET: Bringing Lower-Cost Biosimilar Drugs to American Patients | HHS.gov. https://www.hhs.gov/press-room/fact-sheet-bringing-lower-cost-biosimilar-drugs-to-american-patients.html.
6. IQVIA Institute for Human Data Science. (2024, July 7). Assessing the biosimilar void in the US. https://www.iqvia.com/Insights/The-IQVIA-Institute/Reports-and-Publications/Reports/Assessing-the-Biosimilar-Void-in-the-US
7. Internal analysis based on IQVIA sales data and publicly available peers’ pipeline information.