Samsung Bioepis’ Second Quarter 2025 Biosimilar Market Report Highlights US Debut of Ustekinumab Biosimilars with WAC discounts over 80% and Regulatory Streamlining

• First wave of Stelara (ustekinumab) biosimilars show steep Wholesale Acquisition Cost (WAC) discounts greater than 80%
• Provides insights to regulatory streamlining in biosimilar development currently under review by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)

Samsung Bioepis Co., Ltd. today released its Second Quarter 2025 Biosimilar Market Report, which provides the second quarter 2025 Average Sales Price (ASP) and Wholesale Acquisition Cost (WAC) of the commercially available biosimilars in the US, as well as the price and market share trends since each biosimilar’s launch.

“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 US Commercial Operations at Samsung Bioepis. “In addition, the FDA and EMA have intensified their efforts to streamline biosimilar development. Notably, the agencies are considering waiving Comparative Clinical Efficacy Studies (CES) and interchangeability switching studies in 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 Mar 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 US market.
• Excluding Cordavis private-label products, adalimumab biosimilars’ market share has modestly increased in 2025 as Humira’s market share continues to slowly erode.
• 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 (CES) 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.^1,2 The FDA has suggested in its June 2024 guidance that robust analytical, functional, and pharmacokinetic (PK) data may, in some cases, provide sufficient evidence without the need for large-scale switching studies³.
• Analyses suggest development streamlining proposals could reduce the US 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 savings⁴. 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 (CMS) publishes updated quarterly ASP values for each product. In this edition, the methodology for calculating the ASP is described in detail, as well as how ASP based reimbursement impacts the biosimilar marketplace.

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

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.

References

¹ Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?. Biodrugs. (Oct 13, 2023). Retrieved Mar 2025 from https://link.springer.com/article/10.1007/s40259-023-00631-4

² Reflection Paper on a Tailored Clinical Approach in Biosimilar Development. EMA. (Apr 01, 2025). Retrieved Apr 2025 from https://www.ema.europa.eu/en/reflection-paper-tailored-clinical-approach-biosimilar-development

³ Considerations in Demonstrating Interchangeability With a Reference Product: Update. FDA. (Jun 2025). Retrieved Mar 2025 from https://www.fda.gov/media/179456/download

⁴ Considerations in Demonstrating Interchangeability With a Reference Product: Update. FDA. (Jun 2025). Retrieved Apr 2025 from https://www.fda.gov/media/179456/download

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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.