Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share

Adalimumab biosimilars have seen a ramp up in market share, going from 2% in early 2024 to 22%, driven largely by biosimilar uptake through private label brands, according to Samsung Bioepis’ fourth quarter 2024 US Biosimilar Market Report.¹

On average, biosimilars have gained 53% market share within 5 years post initial launch. | Image credit: Suriya - stock.adobe.com

As of September 2024, the FDA has approved 61 biosimilars across 17 molecules, of which 41 biosimilars have launched on the US market. There have been 4 new approvals over the last quarter (1 eculizumab, 2 aflibercept, 1 ustekinumab). Overall, the average sales prices (ASPs) of all biosimilars has decreased by 53% over the first 5 years post first biosimilar launch.

Since the launch of the first adalimumab biosimilar (Amjevita) in January 2023, adalimumab biosimilars have had trouble gaining market share, largely because of payers and pharmacy benefit managers choosing to prioritize the reference product Humira (adalimumab) for formularies, rebates, and reimbursements over biosimilar options.² However, in recent months, several of the biggest PBMs (CVS Caremark, Evernorth, GoodRx) have announced plans to either add biosimilars to formulary list or replace the originator with a biosimilar option. Costco and the Mark Cuban Cost Plus Drug Company have also made deals with manufacturers to offer an adalimumab biosimilars at a low cost to patients.

Adalimumab biosimilar companies have also taken a unique approach to pricing, with many options having 2 wholesale acquisition costs (WACs), usually in the form of an unbranded agent with a low WAC price and a branded product with a high WAC. Hadlima (adalimumab-bwwd), Yusimry (adalimumab-aqvh), and Simlandi (adalimumab-ryvk) offer a low WAC with about 85% to 86% less than Humira. Amjevita (adalimumab-atto), Cyltezo (adalimumab-adbm), Hyrimoz (adalimumab-adaz), Hulio (adalimumab-fkjp), Idacio (adalimumab-aacf), Yuflyma (adalimumab-aaty), and Abrilada (adalimumab-afzb) offer multiple pricing options. Private label brands also offer alternative WAC prices.

During Q2 2024, 2 tocilizumab biosimilars referencing Actemra launched, launching with WAC discounts of 16% and 26% lower than the vial formulation of the originator ($2220 vs $1960 vs $2656, respectively). The WAC of the originator’s prefilled syringed and autoinjector presentations are $1175. Ranibizumab biosimilars have also rose in market share, grasping 56% since their introduction in Q2 2022.

Market share for insulin and infliximab biosimilars has remained steady, falling 1% and 2%, respectively, from Q2 2024. Additionally, Retacrit, the only epoetin alfa biosimilar on the market, holds about a third of the market, with the 2 reference agents (Epogen and Procrit) maintaining a combined 62% share.

In the oncology space, biosimilar market share remains high, with trastuzumab biosimilars holding 86%, bevacizumab biosimilars having 89%, and rituximab biosimilars holding 75%. Supportive care biosimilars for filgrastim have 87% market share; however, the average ASP of these products has gone up 24% since last quarter. Pegfilgrastim biosimilars hold 85% and the ASP has gone down by 5% since the previous quarter.

Biosimilars have saved payers an average of $1.6 per member per month (PMPM), with some seeing up to $6 PMPM. These savings are often reinvested to offset drug costs and reduce premium growth, providing relief in costly biologic markets and enhancing patient access to therapies. Biosimilar savings are typically reinvested by US payers to offset rising drug costs and slow premium growth. This cost relief in expensive biologic markets allows health care funds to be redirected toward new therapies and innovation. As biologic costs decrease, payer restrictions on drug use may also be eased, improving patient access to biologic therapies and leading to better patient outcomes.

In a survey for the report, payers suggested various strategies to optimize biosimilar adoption in the US. They proposed incentivizing government programs like Medicaid and Medicare to prefer biosimilars over reference biologics and eliminating "grandfathering" requirements that hinder switching. To reduce administrative burdens, payers recommended viewing all biosimilars as interchangeable for pharmacies and providers.

Additionally, they advocated for increased competition by streamlining regulatory approval pathways. Speeding up conversions to biosimilars is seen as crucial for realizing long-term cost savings, even if there are initial costs. Strengthening step therapy, such as promoting biosimilar switching or applying it to patients on reference biologics, is also recommended. To further align payer and patient incentives, payers may consider novel benefit designs, like a dedicated biosimilar tier.

“Biosimilars have already contributed $36 billion in savings to the US healthcare market, but there is still significant room for growth. Our hope is that stakeholders will become more familiar with biosimilars and continue to embrace their potential,” wrote Thomas Newcomer, vice president and head of market access at Samsung Bioepis US.

References

1. Samsung Bioepis biosimilar market dynamics 7th edition, Q4 2024. Samsung Bioepis. October 10, 2024. Accessed October 11, 2024. https://www.samsungbioepis.com/en/etc/gadown.do?filename=SB+Biosimilar+Market+Report+Q4+2024.pdf&utm_source=pdfClick&utm_medium=filedown&utm_campaign=marketReport

2. Jeremias S. Happy birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars®.January 31, 2024. Accessed October 11, 2024. https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition