'Yellow Light' Targets US Humira Biosimilar... Can It Surpass PBM?

Patients' Access to Medication Requires PBM Listing
Express Joins OptumRx in Excluding Domestic Similars
CVS Unannounced... Possibility of Additional Listings Remains Open

Yellow lights have turned on for domestic biosimilars aiming to enter the U.S. market for the autoimmune disease treatment drug Humira (active ingredient adalimumab), valued at about 24 trillion won. This is because the essential listing on the prescription formulary of Prescription Benefit Managers (PBMs), crucial for market penetration, has not been rapidly achieved, raising concerns that these biosimilars may become latecomers.

On the 10th (local time), Express Scripts, one of the three major PBMs in the U.S., announced that it would list Boehringer Ingelheim's 'Cyltezo', Sandoz's 'Hyrimoz', and Sandoz's unbranded 'adalimumab-adaz' among Humira biosimilars on the National Preferred Formulary (NPF). Earlier, OptumRx, another of the three major PBMs, had included Amgen's 'Amjevita' and the unbranded 'adalimumab-atto', both launched in January, on its standard formulary and announced on the 23rd of last month that it would list Cyltezo, Hyrimoz, and adalimumab-adaz as well.

In other words, although the U.S. Humira biosimilar market opened on the 1st, Samsung Bioepis's 'Hadlima' and Celltrion's 'Yuflyma', biosimilars developed domestically, have yet to successfully penetrate key PBMs.

If not listed on PBMs, sales are virtually impossible... Pricing strategies complicated by 'rebates'

The reason why targeting PBMs is important is that the structure of the pharmaceutical market in the U.S. differs from that in Korea. Additionally, rebates, which are illegal in Korea, are permitted in the U.S., making market access strategies even more complex.

First, PBMs negotiate drug prices and rebate levels with pharmaceutical companies on behalf of insurers and manage formularies, which are lists of drugs that can actually be prescribed at pharmacies. In many cases, public insurance sectors also outsource these tasks to PBMs. For certain specialty drugs like Humira, sales at pharmacies are virtually impossible unless they are listed on PBM formularies. Therefore, the number of formularies on which a product is listed and the tier placement within those formularies determine the product's success or failure.

Celltrion's Humira biosimilar 'Yuflyma'
[Photo by Celltrion Healthcare]

With rebates combined into this structure, the prices of launched biosimilar products vary, and even within the same company, unbranded products with different discount rates are released. For example, Organon, the distributor of Hadlima, set the wholesale acquisition cost (WAC) at $1,038 (about 1.34 million won), an 85% reduction compared to Humira's monthly price of $6,922 (about 9 million won). In contrast, Celltrion Healthcare, responsible for overseas sales of Yuflyma, priced its WAC only 5% lower than the original at $6,576.5 (about 8.5 million won). This results in a monthly cost difference of about $5,500 even among domestic biosimilars.

Other biosimilar companies have also adopted similar pricing strategies. Boehringer Ingelheim, which is the only one among Humira biosimilars to secure 'interchangeability', priced Cyltezo about 5-7% lower than the original, similar to Celltrion Healthcare. Amgen and Sandoz set discount rates of about 5-7% for their branded products, while adopting a complex strategy of lowering prices of unbranded products sold under the generic name by up to 81%.

Samsung Bioepis's Humira biosimilar 'Hadlima'
[Photo by Samsung Bioepis]

Those adopting a high-price strategy prioritize listing on major PBMs. Since rebates paid to PBMs are calculated as a percentage of the drug price, higher prices actually provide PBMs with more rebates. From the PBM perspective, drugs with smaller discounts that sell more bring greater benefits. Conversely, the low-price strategy may succeed in PBM listing by accepting some loss in rebate competitiveness through policy pressure to adopt lower-priced products. Those employing a complex strategy aim to quickly capture the market by deploying all these approaches simultaneously.

PBM formulary doors closing rapidly... Celltrion to announce results by the end of this month

Currently, the U.S. Humira PBM market is an oligopoly formed by three major PBMs?CVS Caremark (33%), Express Scripts (24%), and OptumRx (22%)?which together hold about 80% market share. Success in getting listed on their formularies can significantly increase market share, but failure to do so will make future market penetration difficult. News that Yuflyma and Hadlima were excluded from OptumRx's initial formulary list caused the stock prices of related companies such as Celltrion, Celltrion Healthcare, and Samsung Biologics to fall domestically.

However, since CVS Caremark, which holds the highest market share, has not yet listed Humira biosimilars on its formulary, and other PBMs have not categorically ruled out listing other biosimilars, the possibility of market penetration remains open.

OptumRx is reportedly not planning to add listings beyond the already published formulary list, but this list only covers 55% of private insurance within OptumRx. This means there is still a possibility of listing on the remaining 45% related to public insurance. Huh Hyemin, a researcher at Kiwoom Securities, explained, "Due to the opaque organizational nature of PBMs, additional listings are also expected." Express Scripts also stated, "As new biosimilar products are launched, we will continue to individually review whether each product meets the clinical criteria required for cost savings and formulary inclusion," leaving the door open for additional listings.

On the 11th, Celltrion Healthcare posted a message titled 'A Letter to Our Shareholders' on its website, stating, "We are actively pursuing PBM listings with the goal of being included in formularies covering 40% of the U.S. adalimumab market," and "There are ongoing contract negotiations, and we plan to announce results by the end of this month after consultations with multiple PBMs." Samsung Bioepis is also reportedly continuing related negotiations with major PBMs through Organon.

This content was produced with the assistance of AI translation services.