Celltrion's 'Uplima' Enters Top 3 US PBMs... "Securing 19% Coverage Rate Within This Month"

Among the 3 Major PBMs, OptumRx Included in Public Insurance Prescription List
First Domestic Humira Biosimilar Listed Among Top 3 PBMs

Targeting Public Insurance with Preferred Drugs and High Concentration Advantages
Epis' 'Hadlima' Also Achieves 20% Insurance Access Rate

Celltrion Healthcare's Humira (active ingredient adalimumab) biosimilar 'Yuflyma' has succeeded in being listed on the formulary of one of the three major U.S. pharmacy benefit managers (PBMs). This marks the beginning of a full-scale breakthrough in the U.S. market for domestically produced Humira biosimilars, which had seemed stagnant.

According to industry sources on the 24th, OptumRx, one of the major PBMs in the U.S., recently added Yuflyma and Boehringer Ingelheim's biosimilar 'Cyltezo' alongside Humira as preferred drugs on the Medicare formulary, a public insurance program. U.S. public insurance is divided into Medicare, which targets the elderly aged 65 and over, and Medicaid, which supports medical expenses for low-income groups. Medicare is known to account for the vast majority of this segment.

This is the first time a domestically produced biosimilar has been listed as a preferred drug on the formulary of one of the three major U.S. PBMs. The importance of PBMs stems from the unique characteristics of the U.S. market, which differ from Korea. Adalimumab, a specialty drug administered by self-injection, falls under the 'pharmacy benefit' market. To distribute and sell drugs in this market, the drug must be listed on formularies selected by PBMs acting on behalf of insurers. PBMs negotiate drug prices and rebate levels with pharmaceutical companies during this process. Many public insurance programs also outsource these tasks to PBMs. Therefore, for sales within the U.S., it is crucial how many PBM formularies a drug is listed on and at what tier.

As of last year, the U.S. Humira PBM market is an oligopoly dominated by three large PBMs?CVS Caremark (33%), Express Scripts (24%), and OptumRx (22%)?which together hold an 80% market share. Although domestically produced biosimilars like Yuflyma and Samsung Bioepis's 'Hadlima' have been listed on formularies of smaller PBMs or insurers that are not PBMs, they had not entered the formularies of these major PBMs. This raised ongoing concerns about failing to penetrate the U.S. adalimumab market worth approximately $18.6 billion (about 24.6 trillion KRW).

However, on the 1st of this month, Celltrion Healthcare announced that it had signed a rebate contract at the end of last month to list Yuflyma as a preferred drug on the public insurance market of one of the major U.S. PBMs. Celltrion Group Chairman Seo Jung-jin revealed that the contract was with a payor covering 11% of the entire U.S. market. It was later confirmed that this contract pertains to OptumRx's Medicare formulary, indicating a steady approach to the U.S. market.

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

With this formulary listing, Yuflyma now has access to 14% of the entire U.S. Humira market. This scale is the largest among public insurance formularies managed by individual PBMs. The U.S. adalimumab market is almost evenly split between public insurance (47%) and private insurance (53%). Furthermore, Chairman Seo stated, "we expect to finalize a contract with a payor covering 5% market share within this month," suggesting that access to about 20% of the market through PBMs could be achieved within this month alone.

Being listed as a preferred drug means securing a definite access route. Drugs on PBM formularies do not hold equal status. If a drug is not listed as a preferred drug, which is the highest priority tier, it is deprioritized in insurance reimbursement. This makes reimbursement practically difficult and hospitals tend to avoid prescribing non-preferred drugs for this reason. However, Yuflyma has gained significant competitiveness by becoming the first domestic Humira biosimilar to be listed as a preferred drug on a PBM formulary.

It is also encouraging that Cyltezo is the only other biosimilar listed alongside Yuflyma on the OptumRx Medicare formulary. Cyltezo is the only Humira biosimilar approved as interchangeable, making it a strong competitor. However, it has the limitation of being developed only in a low-concentration formulation. In contrast, Yuflyma was developed solely as a high-concentration formulation (HCF), which reduces the drug dosage by half. According to Symphony Health, last month, high-concentration formulations accounted for 87% of adalimumab prescriptions in the U.S., suggesting that Yuflyma could have a significant advantage over Cyltezo in competition.

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

Meanwhile, Samsung Bioepis's Hadlima continues to increase its market share. With a market share of 6.4%, it has been included in the formulary of Prime Therapeutics, a PBM ranked sixth, and although not a PBM, it has secured about 20% market access through listings on major insurer formularies such as UnitedHealthcare, Cigna Healthcare, and Centene.

Celltrion Healthcare stated, "We are negotiating with multiple PBMs that align with Celltrion Healthcare's profitability strategy," and added, "We will do our best to list Yuflyma on insurance markets covering 40% of the U.S. population within this year." To this end, Celltrion Group plans to obtain additional approvals for dosages of 20 mg/0.2 ml and 80 mg/0.8 ml, in addition to the already approved 40 mg/0.4 ml, aiming to secure biosimilar competitiveness most similar to Humira.

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