Biosimilar Market Share: Growth and Price Trends in Q1 2025

Samsung Bioepis' Q1 2025 report shows oncology, ophthalmology, and pegfilgrastim biosimilars have gained significant market share, while immunology, filgrastim, epoetin alfa, and insulin glargine biosimilars have grown more slowly. | Image Credit: sirichai - stock.adobe.com

Oncology, ophthalmology, and pegfilgrastim biosimilars reached an average biosimilar market share of 81% by 5 years post launch, according to a Samsung Bioepis’ First Quarter (Q1) 2025 Biosimilar Market Report.¹

Each biosimilar gained an average of 53% market share following initial launch. For every molecule, a unique market uptake speed is categorized as either fast or slow. For example, in comparison, immunology, filgrastim, epoetin alfa, and insulin glargine biosimilars only achieved an average of 26% market share after 5 years on the market.

Samsung Bioepis has published quarterly biosimilar market reports since April 2023. These reports provide the latest market share and price trends for all biosimilars available in the US. The reports are released after CMS publishes its updated quarterly average sales price (ASP) values for each product.² The CMS payment policy for qualifying biosimilars is based on the biosimilar ASP plus 6% of the originator's ASP.¹

In October 2022, CMS issued a payment increase to existing qualifying biosimilars that reimbursed biosimilars at the ASP plus 8% of the originator’s ASP. The payment increase remains in effect until 2027 and applies to biosimilars with an ASP lower than the originator.

At the end of Q4 2024, there were 64 FDA-approved biosimilars across 17 unique biological molecules, with 41 total biosimilars launched on the US market. The wholesale acquisition cost (WAC) prices for oncology biosimilars had a 10% to 25% discount compared with reference products. The Q1 2025 biosimilar ASP discounts averaged 52% for trastuzumab, 49% for bevacizumab, and 66% for rituximab markets. The WAC discounts for supportive care biosimilars are between 18% and 67% compared with their reference products.

Immunology and ophthalmology biosimilars experienced modest discounts. Both infliximab reference products and biosimilars had significantly lower WACs, ranging from 19% to 59% in discounts.

Adalimumab biosimilar market share reached 23% in November 2024, a 1% increase since August. A majority of biosimilar gains are due to Hyrimoz (adalimumab-adaz) and Hadlima (adalimumab-bwwd). These biosimilars have provided the market with diverse WAC pricing options that offer reduced prices or dual pricing options.

Adalimumab biosimilars have disrupted the market with significantly lower prices. Hadlima, Yusimry (adalimumab-aaty), and Simlandi (adalimumab-aqvh) stand out with WACs 85% to 86% lower than Humira. Other brands employ flexible pricing models, offering both high and low WAC options. Private label strategies further complicate pricing, with some manufacturers increasing WACs for their private label versions, while others maintain low prices consistent with their non–private label counterparts.

In Q3 2024, strong market shares were held across 86% of the trastuzumab market, 90% of the bevacizumab market, 76% of the rituximab market, and 85% of the pegfilgrastim market, with little to no changes from the previous quarter. The report for Q1 2025 claims an average ASP of $1468, depicting a 7% increase compared with the last quarter. The past few quarters have shown ASP increases in a highly competitive market.

On the other hand, the biosimilar bevacizumab market has achieved 90% market share, which is only a 1% increase since last quarter. For Q1 2025, the ASP of all bevacizumab biosimilars is $1399, a 1% decrease from last quarter. The biosimilar market share for rituximab remained unchanged from Q3 2024 compared with the last quarter (76%). The ASP for rituximab biosimilars was $1247, reflecting a 3% decrease while the ASP for pegfilgrastim biosimilars decreased slightly to $2050, representing a 0.5% decline.

Lower priced biosimilars are dominating the rituximab market, with Riabni (rituximab-arrx) growing in market share as its ASP declines. The pegfilgrastim market contains more stable ASPs among market leaders like Udenyca (pegfilgrastim-cbqv), and Fulphila (pegfilgrastim-jmdb). The only biosimilar of epoetin alfa, Retracrit (epoetin alfa-epbx), maintains over a third of the market share, with the 2 reference products (Actemra) maintaining around 60% to 70% of the market.

Tocilizumab biosimilars have not made significant waves in the biosimilar market yet because they were launched only a few months ago. The ASP of all biosimilar products is $1840 in Q1 2025, but as the market continues to emerge, ASP discounts are growing modestly.

Similarly, the insulin glargine market share remained unchanged from last quarter. Sanofi implemented a dual pricing strategy that has allowed Lantus, both branded and unbranded, to remain as the market leader.

“This year, the industry is set to witness the launch of biosimilars for aflibercept, ustekinumab, and denosumab, and we are eager to track the market movements that they will generate,” stated Thomas Newcomer, vice president and head of market access at Samsung Bioepis.

As the biosimilar landscape continues to evolve, market penetration rates vary across different therapeutic areas. With new biosimilars set to enter the market, it is crucial to monitor their impact on pricing, market share, and patient access.

References

1. Samsung Bioepis biosimilar market dynamics 8th edition, Q1 2025. Samsung Bioepis. January 15, 2025. Accessed January 21, 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 21, 2025. https://www.globenewswire.com/news-release/2025/01/16/3010713/0/en/Samsung-Bioepis-Releases-First-Quarter-2025-US-Biosimilar-Market-Report.html