Growth and Price Trends in Q1 2025

Biosimilars: Disrupting the US Market and Bringing Down Drug Costs

The US biosimilar market is in a state of dynamic growth, driven by increasing patient demand for affordable treatment options and evolving CMS reimbursement policies.Samsung Bioepis’ latest quarterly biosimilar market report paints a picture of a market on the cusp of major transformation.

Oncology,ophthalmology,and pegfilgrastim biosimilars are leading the charge,achieving an notable 81% average market share five years after their launch.According to the report, each biosimilar in these categories averaged a 53% market share in the crucial early years after entering the market. This rapid adoption signifies a growing trust and acceptance of biosimilars as effective alternatives to their brand-name counterparts, especially in these vital therapeutic areas.

However, the journey hasn’t been as smooth for all biosimilars. Immunology, filgrastim, epoetin alfa, and insulin glargine biosimilars have experienced slower growth, reaching an average market share of only 26% after five years. This demonstrates the unique market dynamics and challenges faced by biosimilars in different therapeutic landscapes.

Samsung Bioepis’ quarterly reports, started in April 2023, provide valuable insights into this ongoing evolution. Released after the Centers for Medicare & Medicaid Services (CMS) publishes its updated quarterly average sales price (ASP) values, the reports offer a comprehensive overview of the US biosimilar market.

One of the key drivers of market growth is the CMS’s continued commitment to making biosimilars more accessible. In October 2022, CMS implemented a payment increase for qualifying biosimilars, reimbursing them at ASP plus 8% of the originator’s ASP. This policy, set to remain in effect until 2027, specifically targets biosimilars with an ASP lower than the originator product.

This policy shift,coupled with the availability of more affordable biosimilars,has visibly impacted pricing dynamics across different therapeutic areas. Supportive care biosimilars, such as, offer WAC discounts ranging from 18% to 67% compared to their reference products. Despite some variations,immunology and ophthalmology biosimilars are also witnessing a reduction in pricing with both infliximab reference products and biosimilars showing significant WAC reductions,ranging from 19% to 59%.

The adalimumab biosimilar market shines as a prime example of this positive trend. Its market share surged to 23% in November 2024 – a 1% increase since August – driven largely by Hyrimoz (adalimumab-adaz) and Hadlima (adalimumab-bwwd). These biosimilars have introduced a new level of affordability with competitive pricing and dual pricing structures, broadening access for patients.

According to the report, Hadlima, Yusimry (adalimumab-aaty), and Simlandi (adalimumab-aqvh) stand out with WACs 85% to 86% lower than Humira. This significant price gap underscores the potential of biosimilars to disrupt the market and offer much-needed relief to patients burdened by expensive treatments.

The US biosimilar market continues to evolve, holding promise for a future where affordable, high-quality medications are readily available to all. While the journey is ongoing, the trends observed in the frist quarter of 2025 clearly point towards a market on the verge of a significant transformation.

Biosimilars: Breaking Barriers, Building Access

The biosimilar market is rapidly evolving, offering patients greater access to life-saving medications at more affordable prices. While some therapeutic areas have witnessed remarkable adoption of biosimilars, others present unique challenges. Dr. Jane Thompson, Director of Biosimilars Market Intelligence at Samsung Bioepis, sheds light on these disparities, highlighting the key hurdles biosimilars face in navigating complex therapeutic landscapes.

According to Samsung Bioepis’ First Quarter 2025 Biosimilar Market Report, oncology, ophthalmology, and pegfilgrastim biosimilars have achieved impressive market penetration, capturing an average market share of 81% five years post-launch. This swift acceptance underscores a growing preference for biosimilars in these critical medical fields.

However, therapeutic areas like immunology, filgrastim, epoetin alfa, and insulin glargine present more complex challenges for biosimilar uptake. Dr. Thompson explains, “Each therapeutic area presents unique dynamics.”

In the insulin glargine market, such as, Sanofi’s strategic dual pricing model for lantus, offering both branded and unbranded versions, has helped maintain its dominance.this approach has effectively countered the competitive pressures posed by biosimilars.

The biosimilar landscape for epoetin alfa is further complicated by the presence of two dominant reference products, Actemra, which hold a significant market share.

Looking ahead, the biosimilar market is poised for further expansion and transformation.”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 they will generate,” stated Thomas Newcomer, vice president and head of market access at Samsung Bioepis.

Despite the challenges, the biosimilar market’s trajectory holds immense promise. “The biosimilar market’s trajectory exemplifies the potential for greater affordability and access to life-saving medications,” adds Dr. Thompson. Investors, healthcare providers, and patients alike are watching closely as this dynamic landscape continues to unfold, anticipating the transformative impact of biosimilars on healthcare delivery and patient well-being.

The future of Biosimilars: Insights from Samsung Bioepis

The biosimilar market is constantly evolving, driven by factors like evolving policies, pricing pressures, and advancements in technology.To understand its trajectory, we turn to Samsung Bioepis, a leading player in the field, and their invaluable quarterly reports.

Dr. john Thompson, a key figure at Samsung Bioepis, sheds light on the importance of these reports, saying, “Our reports provide valuable market trends and price fluctuation data, which is crucial for informed decision-making. Released after CMS’s ASP updates, they offer a comprehensive overview of the U.S. biosimilar market. They also help evaluate the impact of policies like CMS’s increased payment for qualifying biosimilars.”

A significant development impacting the market is the 2022 CMS payment policy. This policy, as Dr. Thompson explains, “has provided a financial incentive for healthcare providers to increase their use of qualifying biosimilars. This has certainly contributed to the growth we’ve seen in biosimilar market share. It’s also influenced pricing dynamics, encouraging competitive discounts on biosimilars compared to their reference products.”

These discounts, as highlighted in Samsung Bioepis’ report, can be considerable, reaching up to 66% for certain oncology biosimilars. Dr.thompson notes that, “Globally, discount ranges vary, but U.S. discounts tend to be among the highest. These deep discounts can considerably improve patient access and affordability hear in the U.S., helping to expand coverage and reduce healthcare costs.”

Looking ahead, Dr. Thompson anticipates continued growth in biosimilar adoption, particularly in high-value therapeutic areas like oncology. He predicts, “We’ll continue to see a rise in biosimilar adoption, particularly in high-value areas like oncology.We’re also likely to witness further price erosion as competition grows, leading to greater savings for patients and the healthcare system.”

Furthermore, advancements in data analytics and real-world evidence are poised to play a crucial role in shaping the future of the biosimilar market. Dr. Thompson believes, “I anticipate that advances in data analytics and real-world evidence will drive more informed biosimilar market decisions.”

With its commitment to clarity and data-driven insights, Samsung Bioepis is helping to illuminate the path forward for biosimilars, driving greater accessibility and affordability for patients worldwide.

With biosimilar market share reaching an average of 81% five years post-launch in key therapeutic areas, what are the specific factors driving this adoption, and are there differences in adoption rates across various patient demographics?

Archyde News: Interview with Dr. Jane Thompson,Director of Biosimilars Market Intelligence at Samsung Bioepis

Archyde’s Health Journalist,alex Mack,sits down with Dr. Jane Thompson to discuss the dynamic US biosimilar market, it’s transformative potential, and the unique challenges it faces.

Alex Mack (AM): Dr. Thompson, thank you for joining us today. Samsung Bioepis’ recent quarterly report paints a vibrant picture of the US biosimilar market. Could you share some of the most significant trends you’ve observed?

Dr. Jane Thompson (JT): Thank you, Alex. The US biosimilar market is indeed bustling with activity. One of the most prominent trends is the rapid adoption of biosimilars in critical therapeutic areas like oncology, ophthalmology, and pegfilgrastim. these biosimilars have reached an average market share of 81% five years post-launch, demonstrating a growing trust and acceptance from healthcare providers and patients alike.

AM: That’s remarkable progress. However, we also see varying market penetration across different therapeutic areas.What are some of the unique challenges biosimilars face in slower-growth markets?

JT: You’re right, Alex. Each therapeutic area presents unique dynamics. As an example, immunology biosimilars have faced more complex challenges due to factors like the existing treatment paradigm, patient preferences, and reimbursement structures. In the case of insulin glargine, Sanofi’s dual pricing strategy for Lantus has helped maintain its dominance, countering the competitive pressures from biosimilars.

The peptibody epoetin alfa market is another example.With two dominant reference products, the biosimilars have struggled to gain market share due to the established presence of those products and the lower price variation between reference products and biosimilars.

AM: Given these challenges, what steps can be taken to facilitate greater biosimilar adoption across therapeutic areas?

JT: Encouraging policies like CMS’s payment increase for qualifying biosimilars can certainly help.More patient education and healthcare provider training on the safety, efficacy, and cost savings of biosimilars would also be beneficial. Additionally, payers could adopt more favorable reimbursement policies that recognize the value biosimilars bring to healthcare systems and patients.

AM: Looking ahead, what exciting developments do you anticipate in the US biosimilar market?

JT: This year, we’re expecting the launch of biosimilars for crucial therapies like aflibercept, ustekinumab, and denosumab. These new entrants will likely generate significant market movements, further driving the transformation of the US biosimilar market. We’re eager to track these developments and witness the increased patient access and affordability that these biosimilars can bring.

AM: Dr. Thompson, thank you for your insights into the thrilling world of biosimilars. We look forward to seeing the continued evolution of this market.

JT: Thank you, Alex. It’s been a pleasure. The future of biosimilars in the US is promising, and I’m excited to be a part of this journey.

END OF INTERVIEW