Epis Humira Biosimilar 'Hadlima' Enters US Prescription Market

Major Insurer Cigna Healthcare
Successfully Listed in Prescription Formulary

Separate from PBM Formulary Listing
Immediate Prescriptions Not Possible

Samsung Bioepis's autoimmune disease treatment 'Humira' (active ingredient Adalimumab) biosimilar 'Hadlima' has entered the U.S. market prescription list for the first time. Although it is not yet listed on the formulary of the key U.S. prescription market Pharmacy Benefit Manager (PBM), this marks the initial breakthrough into the prescription market.

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

On the 10th (local time), Cigna Healthcare, an insurer under the large U.S. insurance group Cigna, announced that it will add four biosimilar products, including Hadlima, as preferred drugs to its formulary starting this September. Along with Samsung Bioepis's Hadlima, the list includes Boehringer Ingelheim's 'Siltezo', Sandoz's 'Hyrimoz', and Sandoz's unbranded 'Adalimumab-adaz'.

However, this is not an official PBM listing. Express Scripts, a PBM under the Cigna group, stated that among the four biosimilars listed by Cigna Healthcare, it will include only three?excluding Hadlima?in its National Preferred Formulary (NPF). Cigna Healthcare also explained that while the three biosimilars will be listed on the NPF, standard formulary, and official commercial formularies, Hadlima will be added separately as a preferred product based on its value, advantages, and total cost savings, showing a somewhat distinct approach.

Complex U.S. Prescription Market... Difficult to Sell Without PBM Approval Even If Insurer is Penetrated

To understand this situation, one must first understand the U.S. insurance market. Adalimumab, a specialty drug prescribed for self-administration, falls under the 'pharmacy benefit' market. For distribution and sales in this market, drugs must be listed on formularies selected by PBMs acting on behalf of insurers. Generally, formularies of PBMs and insurers within the same group list the same drugs, so these two are often considered synonymous.

However, in the case of Cigna Healthcare and Express Scripts, the formularies of the insurer and PBM within the same group do not match. This means that patients covered by Cigna Healthcare insurance but subject to Express Scripts' formulary will find it difficult to receive prescriptions for Hadlima. Hadlima can only be prescribed after it is additionally listed on Express Scripts' formulary or on another PBM's formulary.

However, Hadlima and another Korean Humira biosimilar, 'Yuflyma', have not yet been officially listed on any PBM formularies. Among the major PBMs that have disclosed their formularies so far, Express Scripts includes only the three biosimilars mentioned above, while OptumRx additionally lists Amgen's 'Amjevita' and the unbranded 'Adalimumab-atto'.

An industry insider commented, "This is quite an unusual situation," analyzing that "large insurers seem to recognize demand not only for high-priced products with high rebates but also for low-cost products aimed at expanding patient access."

In other words, this is a peculiar situation caused by the unique rebate system in the U.S. market alongside PBMs. Currently, the prices of Humira biosimilars vary by company. Organon, the distributor of Hadlima, set the wholesale acquisition cost (WAC) at $1,038 (approximately 1.34 million KRW), an 85% reduction compared to Humira's monthly price of $6,922 (about 9 million KRW). In contrast, Celltrion Healthcare, responsible for overseas sales of Yuflyma, priced its WAC at $6,576.5 (about 8.5 million KRW), only 5% lower than the original. This results in a monthly cost difference of about $5,500 between two Korean biosimilars.

Other biosimilar companies also adopt different pricing strategies, with some applying only 5-7% discounts and others setting high discounts in the 80% range. Some companies employ a mixed strategy by offering both high-priced branded products and unbranded products sold under the generic name.

Through this, companies with high-price strategies aim to increase rebates paid to PBMs to boost PBM adoption preference and prioritize targeting them, while those with low-price strategies plan to succeed in PBM listings by accepting some loss in rebate competitiveness and relying on policy pressure to adopt low-cost products.

Currently, the U.S. Humira PBM market is an oligopoly with three major PBMs?CVS Caremark (33%), Express Scripts (24%), and OptumRx (22%)?holding about 80% market share. Although CVS Caremark, which has the highest market share, has not yet listed Humira biosimilars on its formulary, and other PBMs have not ruled out listing other biosimilars, the possibility of market penetration remains open.

Celltrion Healthcare announced on its website the previous day in a 'Letter to Shareholders' that it is actively pursuing PBM listings with the goal of being listed on formularies covering 40% of the U.S. adalimumab market. It stated, "There are ongoing contract negotiations, and we plan to announce results by the end of this month after discussions 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.