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Unlocking insights from the ‘Samsung Bioepis’ US Quarterly Biosimilars Market Report’
With the upcoming Presidential Election in the United States, we wanted to take this opportunity to address an important issue at stake, regarding drug pricing and medicine access in the US.
Biologic medicines are among the most innovative drugs that treat many difficult medical conditions, yet they account for approximately 46% of medicine spending in the US.1 As patents expire for many of the branded biologics, biosimilars are introduced to the market, stimulating market competition and bringing down cost of the biologics category where biosimilars are introduced.2
• Since the entry of the first biosimilar in 2015, biosimilars have generated $36 billion in savings for the US healthcare system.3
• As of October 2024, the U.S. Food and Drug Administration (FDA) has approved a total of 62 biosimilars across 17 unique biological molecules. Of the 62 approvals, 39 biosimilars have launched in the US market.2
• Biosimilar launches have led to significant price decreases over time. The average sales price (ASP) declined by 53% five years post first biosimilar launch with more mature markets demonstrating increasing price concession4.
On average, biosimilars have gained 53% market share within three years post initial launch.4 The oncology class, including supporting care products have seen faster acceptance of biosimilars compared to other therapeutic areas. Some oncology classes have even seen over 80% biosimilar utilization within the first three years. For the infliximab class, the rate of adoption was very slow in the beginning, but now we are starting to see more routine use of biosimilars. Filgrastim biosimilar adoption also continues to grow despite showing slow uptake in the first three years of market entry.5
There is still much room for improvement. Over a year after multiple adalimumab biosimilars launched in July 2023, penetration remains at 22%, with most gains driven by private-label (PL) products, according to IQVIA data.4 There is still room for greater cost savings, and this is not just limited to the adalimumab class, but also to other therapeutic areas such as supportive care, ophthalmology, and future categories such as rare disease. We need to see greater biosimilar utilization in the US to ensure a viable biosimilar market in the future, which ultimately lowers costs to the healthcare system.
The journey towards enhanced biosimilar uptake in the US is a multifaceted one, characterized by variations across therapeutic areas and products. While cost and competition undoubtedly impact acceptance, the interplay of factors such as independent medical guidelines, treatment duration, in addition to access and reimbursement dynamics create a complex landscape. Recognizing and understanding these determinants is essential for stakeholders as they navigate the evolving biosimilar landscape, ultimately striving to optimize patient care while promoting cost-efficiency in the US healthcare system.6
• Guidance provided by the medical organizations plays a pivotal role in shaping healthcare professionals' (HCPs) decisions. For instance, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines are instrumental in oncology.6 In case of rheumatology, there are clinical practice guidelines by American College of Rheumatology (ACR).
• Treatment duration is crucial in determining biosimilar utilization. In chronic conditions, patients tend to remain on therapy for more extended periods, and HCPs are often reluctant to initiate changes when patients are well controlled on a medicine. Conversely, oncology presents a different dynamic. Due to disease progression, patients typically receive therapy for shorter durations, and new patients constitute a larger portion of total treatments. This dynamic contributes to higher biosimilar usage in oncology compared to other therapeutic areas.6
• Access is a paramount factor influencing the pharmaceutical product usage in the US. In a survey with 500 specialty physicians, physicians answered that prescriber choice is driven primarily by formulary status.7 This is also demonstrated in the recent uptake of adalimumab biosimilars. When the originator product was dropped from the formulary and replaced with an adalimumab biosimilar, the switching rate was accelerated.8 The contracting practices of reference product manufacturers can also raise barriers to biosimilar uptake. Big, diversified pharmaceutical companies can use aggressive product incentives, off-invoice discounts, and other tactics to incentivize payers to give reference biologics favorable formulary status.9
The traditional business model has been focused on rebates and not the lowest net cost but the market is seeing new tactics and practices. A recent survey found that biosimilars have encouraged payers to modify their approach eliminating rebates guarantees on originator brands, instead focusing on lowest net cost.4 Payers viewed that there are opportunities to maximize the value by shifting towards lowering net costs instead of maximizing rebates, and continually negotiating with manufacturers for better discounts on preferred agents, with increased competition among manufacturers.
Stakeholders including regulatory, market access, and commercial experts, provide the following perspectives on how government policies could help increase biosimilar adoption in the US4 :
1. Address interchangeability and pharmacy substitution challenges by removing the barriers to switching and designating all biosimilars as interchangeable
2. Encourage patient and provider adoption by addressing the lack of awareness in addition to the misconceptions and misinformation about biosimilars through targeted communication efforts
3. Address perverse incentives which favor higher-cost, higher-rebate products over lower-cost, equally effective biosimilars
1 IQVIA. Biosimilars in the United States 2023-2027. Available at: https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/biosimilars-in-the-united-states-2023-2027. Accessed October 2024.
2 U.S. Food and Drug Administration, Biosimilar Product Information. Available at: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed October 2024.
3 Association for Accessible Medicines. The U.S. Generic & Biosimilar Medicines Savings Report. September 2024. Available at: https://https://accessiblemeds.org/resources/blog/2024-savings-report. Accessed October 2024.
4 Samsung Bioepis. 2024 Fourth Quarter Biosimilar Market Report. samsungbioepis.com/upload/attach/SB+Biosimilar+Market+Report+Q4+2024.pdf. Accessed October 2024.
5 Samsung Bioepis. 2024 Third Quarter Biosimilar Market Report. https://www.samsungbioepis.com/upload/attach/SB+Biosimilar+Market+Report+Q3+2024.pdf. Accessed October 2024.
6 Samsung Bioepis. 2023 Fourth Quarter Biosimilar Market Report. https://www.samsungbioepis.com/upload/attach/SB+Biosimilar+Market+Report+Q4+2023.pdf. Accessed October 2024.
7 Kolbe AR, Kearsley A, Merchant L, et al. Physician understanding and willingness to prescribe biosimilars: findings from a U.S. national survey. BioDrugs. 2021;35:363-372. https://doi.org/10.1007/s40259-021-00479-6
8 Patricia J. Rodriguez PJ, Cartwright BM, Gratzl S, et al. Exploring medication switching trends from Humira to approved biosimilars. https://www.truveta.com/blog/research/humira-and-biosimilars-2024/. Accessed October 2024.
9 Samsung Bioepis White Paper. Improving Understanding and Acceptance of Biosimilars in the United States. November 2021. Accessed October 2024.