Samsung Bioepis releases Q2 2025 Biosimilar Market report

Samsung Bioepis has released its Second Quarter 2025 Biosimilar Market Report, which provides the second quarter 2025 Average Sales Price and Wholesale Acquisition Cost of the commercially available biosimilars in the United States, as well as the price and market share trends since each biosimilar’s launch.

Among the most significant milestones was the launch of ustekinumab biosimilars following the loss of exclusivity for Stelara. This expansion has played a pivotal role in fostering market competition and encouraging more dynamic pricing strategies, the company said.

“The first quarter of 2025 has witnessed substantial developments in market competition and regulatory paradigm. Among the most significant milestones was the launch of ustekinumab biosimilars following the loss of exclusivity for Stelara. This expansion has played a pivotal role in fostering market competition and encouraging more dynamic pricing strategies,” said Thomas Newcomer, vice president, head of U.S. commercial operations at Samsung Bioepis. 

[Read more: Challenges continue, but generics companies see a bright future with biosimilars]

Newcomer added, “In addition, the FDA and EMA have intensified their efforts to streamline biosimilar development. Notably, the agencies are considering waiving Comparative Clinical Efficacy Studies and interchangeability switching studies in the case of FDA, and these streamlined efforts can significantly reduce both time-to-market and development costs. The agencies’ evolving approach is poised to accelerate biosimilar adoption, creating new opportunities for manufacturers while intensifying competition across the sector.”

Some of the key insights from the report include:

• As of March 2025, the FDA has approved a total of 73 biosimilars across 19 unique biological molecules. Of the 73 approvals, 48 biosimilars (66%) have launched in the U.S. market.
• Excluding Cordavis private-label products, adalimumab biosimilars’ market share has modestly increased in 2025 as Humira’s market share continues to slowly erode.
• The beginning of 2025 marked the start of biosimilar competition for ustekinumab upon Stelara's loss of exclusivity, with entrants providing steep WAC discounts of over 80%.
• The ‘Biosimilar Deep Dive’ covers regulatory streamlining for biosimilar development; regulatory agencies are revisiting the requirements for comparative clinical efficacy studies in biosimilar approvals; for biosimilars whose biosimilarity to the reference product is well-established through analytical and functional data and whose mechanism of action is well-understood, CES may be deemed unnecessary. The FDA has suggested in its June 2024 guidance that robust analytical, functional and pharmacokinetic data may, in some cases, provide sufficient evidence without the need for large-scale switching studies.

[Read more: Biosimilar Council comments on IQVIA report on biosimilar void]

• Analyses suggest development streamlining proposals could reduce the U.S. cost of biosimilar development by $50 – $225 million and shorten the development timeline by 1-2 years.
• Currently, 90% of biologics facing patent expiry over the next decade lack biosimilar candidates, limiting potential savings. By shortening development timelines, reducing research and development costs, and expediting regulatory reviews, a more efficient framework could enable developers to pursue biosimilars for biologics previously deemed unfeasible.

Samsung Bioepis has been publishing the Biosimilar Market report quarterly since April 2023 to provide the latest market share and price trends of all biosimilars available in the United States, after the Centers for Medicare & Medicaid Services publishes updated quarterly ASP values for each product. 

To access the Second Quarter 2025 Samsung Bioepis Market Report, please visit here.