Biosimilars Drive Cost Savings and Achieve 53% Market Share Across Treatment Areas

Biosimilar launches have resulted in both 53% market share in biosimilar markets and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to Samsung Bioepis’ First Quarter (Q1) 2025 Biosimilar Market Report.¹

The report details the Q1 2025 average sales price (ASP) and wholesale acquisition cost (WAC) for commercially available biosimilars in the US, along with price and market share trends since each biosimilar's launch.² Samsung Bioepis has been publishing the quarterly report since April 2023, offering insights into market share and pricing trends for all US biosimilars following CMS updates on ASP values, which are done quarterly.

In 2024, there were 15 FDA approvals for biosimilars, 3 of which occurred during Q4, bringing the total number of US approvals to 64. | Image credit: Suriya - stock.adobe.com

In 2024, there were 15 FDA approvals for biosimilars, 3 of which occurred during Q4, bringing the total number of US approvals to 64.³

“As we step into a new year, it's incredible to reflect on how far we have come in the US biosimilar market,” wrote Thomas Newcomer, vice president and head of market access at Samsung Bioepis.¹ “This year, the industry is set to witness the launch of biosimilars in new therapeutic areas and new molecules such as eculizumab, aflibercept, ustekinumab, and denosumab. We are eager to track the market movements that they will generate.”

Oncology was identified as the market with the fastest growing biosimilar uptake, averaging 81% market share after 5 years of biosimilar competition. Immunology, filgrastim, epoetin alfa, and insulin glargine were named the slowest growing biosimilar markets, averaging only 26% market share after 5 years.

For oncology biosimilars, WAC prices offer a modest discount of 10% to 25% compared with their reference products. In Q1 2025, the ASP discounts for biosimilars relative to their reference product ASPs were significantly deeper, averaging 52% for trastuzumab, 49% for bevacizumab, and 66% for rituximab markets. For supportive care biosimilars, WAC discounts range from 18% to 67% compared with their reference products.

Regarding immunology and ophthalmology, more modest discounts were observed. For infliximab, both the reference product and biosimilars entered the market with progressively lower WACs, offering discounts ranging from 19% to 59%.

Updates on Adalimumab Uptake, Prices

As the US nears the 2-year mark of adalimumab biosimilar competition, market share for the 10 biosimilars on the market has grown to 23%, up 1% from August 2024, with most of the share being split between Hyrimoz (adalimumab-adaz) and Hadlima (adalimumab-bwwd).

Hadlima, Yusimry (adalimumab-aaty), and Simlandi (adalimumab-aqvh) stand out with low WAC options, offering prices approximately 85% to 86% lower than Humira. Other brands, including Cyltezo (adalimumab-adbm), Amjevita (adalimumab-atto), Hyrimoz, Hulio (adalimumab-fkjp), Idacio (adalimumab-aacf), Yuflyma (adalimumab-aaty), and Abrilada (adalimumab-afzb), utilize dual or multiple pricing models, providing both high and low WAC options. Private label strategies also play a role in shaping pricing dynamics. Quallent’s approach involved an increase in WAC prices for Simlandi and Cyltezo, while Cordavis offered Hyrimoz at a consistently low WAC, aligning with the pricing of its non–private label counterpart.

Oncology and Supportive Care Updates

As of Q3 2024, oncology biosimilars held strong market shares across key biologic drugs: 86% of the trastuzumab market, 90% of the bevacizumab market, 76% of the rituximab market, and 85% of the pegfilgrastim market, with no significant changes from the previous quarter in most cases.

By Q1 2025, biosimilar ASPs showed varied trends: trastuzumab biosimilars saw a 7% increase, reaching $1468, while bevacizumab ASPs decreased by 1% to $1399. Rituximab biosimilars experienced a 3% decrease in ASP, settling at $1247, and pegfilgrastim ASPs saw a slight decline of 0.5%, reaching $2050.

Within each market, early-to-market biosimilars like Mvasi (bevacizumab-awwb), Zirabev (bevacizumab-bvzr), Riabni (rituximab-arrx), Udenyca (pegfilgrastim-cbqv), and Fulphila (pegfilgrastim-jmdb) continue to dominate, although newer entrants are gradually gaining share, particularly Almysys (bevacizumab-maly), Vegzelma (bevacizumab-adcd), and Riabni. In the epoetin alfa market, Retracrit (epoetin alfa-epbx) holds over a third of the share, with the 2 reference products (Actemra) maintaining around 60% to 70% of the market.

Other Markets

As of the third quarter of 2024, the infliximab biosimilar market share increased to 48%, up by 1% from the previous quarter. By Q1 2025, the average ASP for infliximab biosimilars decreased by 7%, to $169. Despite biosimilar growth, Janssen's competitive ASP pricing and the unbranded Remicade launch in Q4 2021 have helped the reference product retain its market leader position.

In Q3 2024, tocilizumab biosimilars Tofidence (tocilizumab-bavi) and Tyenne (tocilizumab-aazg) launched with WAC discounts of 16% and 26%, respectively. While the tocilizumab biosimilar market is still emerging, Tyenne's 35% ASP discount compared with the originator is driving modest growth relative to Tofidence. By Q1 2025, the average ASP for all biosimilars in this class is $1840.

The insulin glargine biosimilar market share remained at 6% as of Q3 2024. Sanofi's competitive pricing strategy has kept Lantus, both branded and unbranded, as the market leader. These biosimilars are also competing against insulin glargine products that were approved prior to the passing of the biosimilar approval pathway, including Toujeo (Sanofi), Rezvoglar (Eli Lilly), Semglee (Biocon), and Basaglar (Eli Lilly).

Lastly, as of the third quarter of 2024, the ranibizumab biosimilar market share has reached 57%, a 1% increase from the previous quarter. By Q1 2025, the average ASP for all biosimilars is $810, reflecting a 9% decrease compared with the last quarter.

References

1. Samsung Bioepis biosimilar market dynamics 8th edition, Q1 2025. Samsung Bioepis. January 15, 2025. Accessed January 16, 2024. https://www.samsungbioepis.com/en/etc/gadown.do?filename=SB+Biosimilar+Market+Report+Q1+2025.pdf

2. Samsung Bioepis releases first quarter 2025 US biosimilar market report. Press release. Samsung Bioepis. January 16, 2025. Accessed January 16, 2025. https://www.globenewswire.com/news-release/2025/01/16/3010713/0/en/Samsung-Bioepis-Releases-First-Quarter-2025-US-Biosimilar-Market-Report.html

3. Biosimilar approvals. The Center for Biosimilars^®. Updated January 7, 2025. Accessed January 16, 2025. https://www.centerforbiosimilars.com/biosimilar-approvals