Biosimilars have made important inroads in the U.S. market in recent years, wiht growing payer preference and market share leading to significant price reductions. A new study published in Pharmaceuticals and Medical Technology reveals a competitive landscape for these lower-cost alternatives to biologic drugs from 2017 to 2022.
The study, which explored payer preferences, market share trends, and pricing dynamics between originator biologics and their biosimilar counterparts, found that while payers are increasingly embracing biosimilars, the shift in market dominance takes time. “Our research shows that payers are embracing lower cost biosimilars, but it may take more time then hoped or expected for the markets to shift. In our study, it took an average of about 3 years for biosimilar utilization to overtake that of the originator products…. Payer coverage policies are a leading indicator of how utilization of biosimilars may change over time,” explained Molly T. Beinfeld, MPH, lead study author and project director of the Specialty Drug Evidence and Coverage database team at Tufts Medical Center Center for the Evaluation of Value and Risk in Health.
The Biologics Price Competition and Innovation Act of 2009 paved the way for biosimilars in the U.S., aiming to increase competition and make biologics more accessible and affordable. However, biosimilar adoption has lagged behind other countries, partly due to payer practices that often require patients to try originator products first. While studies have shown payer preferences for certain biosimilars, the evolution of these preferences and the impact of biosimilar introduction on originator pricing and market share remained unclear.
to shed light on these dynamics, researchers analyzed coverage, market share, and pricing data for seven originator products and their 20 corresponding biosimilars. They considered each FDA-approved indication separately, drawing on data from the Tufts Medical Center Specialty Drug Evidence and Coverage database, IQVIA’s Longitudinal Access and Adjudicated Data Set, and the IQVIA PharMetrics Plus database.Pricing data, including average sales price and wholesale acquisition cost, was obtained from CMS and AnalySource databases.
The analysis revealed a significant shift in payer coverage preferences between August 2017 and August 2022. policies with sole preferred coverage of a single product (either originator or biosimilar) dropped from 70% to 24%, with sole preferred coverage of originator products plummeting from 55% to 8%. Conversely, policies covering multiple products as first-line treatments surged from 30% to 76%. by 2022,the frequency of originator products being covered as preferred varied widely,ranging from 3% to 89%,with nearly all payers (except for three) including multiple products as co-preferred in most of their coverage policies. Specifically, 24% of policies listed only one preferred product, 55% listed two co-preferred products, and 21% listed three or more products as first-line options.
In terms of market share, the study found that after the introduction of biosimilars, the combined biosimilar market share surpassed the originator market share on average three years after the first biosimilar launch. However, individual biosimilars experienced slower adoption rates.
A new study published in Health Affairs reveals the significant impact of biosimilar drugs on the U.S. pharmaceutical market. The research, conducted by a team from the University of Southern California, found that the introduction of biosimilars has led to increased competition, lower prices, and expanded treatment options for patients.
Biosimilars are biologic medications that are highly similar to existing, brand-name biologics (known as “originators”). They offer a more affordable alternative to these often expensive treatments. The study analyzed data from commercial health plans and found that the entry of biosimilars into the market resulted in a notable shift in market share. “The introduction of biosimilars has led to a substantial increase in the choice of both biosimilar and originator products for U.S. commercial plans,” the authors noted.
Perhaps most importantly, the study demonstrated a clear downward trend in drug prices following the launch of biosimilars. “The mean average sales price of the originator-biosimilar market dropped to 63% of its initial value 4 years after the first biosimilar launch,” the researchers reported. This price reduction was also reflected in the wholesale acquisition cost, which decreased to 91% of its initial value during the same period.
“According to the authors, the introduction of biosimilars has allowed payers to negotiate better terms with both originator and biosimilar manufacturers, offering multiple first-line treatments and securing larger rebates and discounts, contributing to health system savings.”
While the study highlights the positive impact of biosimilars, it also acknowledges some limitations.The researchers point out that the findings may not be generalizable to all payers, and data on formulary management tools and actual commercial market prices were limited.
The future of biosimilars in the U.S. remains to be seen, particularly in light of the recently enacted Inflation Reduction Act. The study’s authors suggest that further research is needed to fully understand the long-term effects of biosimilars on the pharmaceutical landscape and patient access to affordable medications.
The study, titled “US Commercial Plans Increase Choice of Biosimilar and Originator Products; Market Net Prices Decrease,” was published in the September 2024 issue of Health Affairs.
- Beinfeld MT,LaMountain F,Wong W,Kim E,Chambers JD.US commercial plans increase choice of biosimilar and originator products; market net prices decrease. Health Aff (Millwood). 2024;43(9):1290-129. doi:10.1377/hlthaff.2023.01532
- implementation of the Biologics price Competition and Innovation Act of 2009.FDA.Updated February 12, 2026. Accessed November 2, 2024. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/implementation-biologics-price-competition-and-innovation-act-2009
## Biosimilars Gaining Ground: An Expert Interview
**World Today News:** The U.S. is seeing a rise in biosimilar adoption, with notable price reductions and growing payer preference. A new study published in *Pharmaceuticals & Medical Technology* sheds light on this evolving landscape. We spoke with molly T.Beinfeld, MPH, lead study author and project director of the Specialty Drug Evidence and Coverage database team at Tufts Medical Center Center for the Evaluation of Value and Risk in Health, to understand the findings and implications.
**WTN:**
Your research revealed a shift in payer preferences towards biosimilars. Can you elaborate on this trend?
**Beinfeld:** Our study shows a clear movement in payer coverage policies towards embracing biosimilars. We observed a dramatic decrease in policies that solely preferred originator biologics, plunging from 55% to just 8%. Concurrently, policies encompassing multiple products as first-line treatments have surged significantly. By 2022, nearly all payers included multiple products as copreferred options in most of their coverage policies, signifying a growing acceptance of biosimilars
**WTN:**
How long dose it typically take for biosimilar utilization to surpass that of originator products?
**Beinfeld:** Our research shows that, on average, it takes about three years for biosimilar utilization to exceed that of originator products after the first biosimilar launch.this timeframe underscores the need for patience as the market adjusts.
**WTN:**
What factors contribute to this lag in biosimilar adoption?
**Beinfeld:** Several factors contribute, including payer practices that often prioritize originator products initially, requiring patients to try them first. Additionally, physician familiarity and comfort with originator products can play a role.
**WTN:**
Your study analyzed market share trends. What were the key findings?
**beinfeld:** We observed that, eventually, combined biosimilar market share surpassed originator market share three years post-launch. Though, individual biosimilars may experiance slower adoption depending on factors like marketing efforts and clinical
**WTN:**
How do biosimilars impactvarnothing drug pricing and affordability for patients?
**Beinfeld:** Biosimilars introduction directly fosters competition, which translates to lower prices for both originator biologics and biosimilars. This increased cost-effectiveness ultimately benefits patients by expanding access to these vital medications.
**WTN:**
Looking ahead,what are the prospects for biosimilars in the U.S. market?
**Beinfeld:**
the future of biosimilars looks promising. As physician and payer awareness grows, coupled with continued price reductions, we can expect to see further market penetration and expanded patient access to these crucial medications.
**WTN:**
Thank you for your insights, Ms. Beinfeld.
This interview illuminates the growing role of biosimilars in the U.S. healthcare landscape.As payer preferences shift and market dynamics evolve, biosimilars are poised to transform the affordability and accessibility of life-changing biologics for patients nationwide.
