'Now Starting'... Celltrion and Epics Humira Biosimilar Successfully Enter US PBM Market (Comprehensive)

Celt Healthcare "Contracts with Major PBMs and Public Insurance"
Epis Also Secures Contract with a Top 6 PBM
Can They Capture the $25 Trillion US Humira Biosimilar Market?

Domestic biosimilar developers have begun full-scale efforts to capture the U.S. biosimilar market for the autoimmune disease treatment drug Humira (active ingredient adalimumab), valued at approximately 25 trillion won. Following Samsung Bioepis's success with 'Hadlima' in the U.S. prescription market, Celltrion Group's 'Yuflyma' has also secured a listing contract with a major U.S. pharmacy benefit manager (PBM).

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

Celltrion Healthcare announced on the 1st that "at the end of last month, we signed a rebate contract to list Yuflyma as a preferred drug in the public insurance market of one of the major U.S. PBMs." However, the company stated that the target PBM and detailed contract terms will be disclosed after completing the subsequent administrative procedures following the contract signing.

Targeting PBMs is an essential condition for entering the U.S. Humira biosimilar market, which was worth $18.619 billion (approximately 25 trillion won) as of last year. Adalimumab, a specialty drug prescribed for self-administration, falls under the pharmacy benefit market, where drugs must be listed on formularies selected by PBMs acting on behalf of insurers to be distributed and sold. PBMs negotiate drug prices and rebate levels with pharmaceutical companies during this process. Many public insurance sectors also outsource these tasks to PBMs. Therefore, for sales in the U.S., it is crucial how many PBM formularies a drug is listed on and at what tier.

The current U.S. PBM market is an oligopoly dominated by three major PBMs: CVS Caremark (33%), Express Scripts (24%), and OptumRx (22%), which together hold about 80% market share. CVS Caremark, the largest PBM, has not yet listed any biosimilars on its formulary besides the original Humira. Express Scripts listed Boehringer Ingelheim's 'Cyltezo,' Sandoz's 'Hyrimoz,' the unbranded 'adalimumab-adaz,' and Amgen's 'Amjevita' on its formulary on the 10th of last month (local time). OptumRx added these four biosimilars plus Amgen's unbranded 'adalimumab-atto' to its formulary in June.

There have been consecutive incidents where neither Yuflyma nor Hadlima were listed on the formularies of major PBMs. This raised concerns that domestic Humira biosimilars might fail to secure market share, negatively impacting the stocks of Celltrion, Celltrion Healthcare, and Samsung Biologics. However, following Hadlima's inclusion on the formulary of Prime Therapeutics, a PBM ranked sixth with a 6.4% market share as of the 12th of last month (local time), and Yuflyma's successful contract with a major PBM, a counterattack by domestic biosimilars appears to be underway.

In particular, although Celltrion Healthcare has not yet disclosed the target PBM due to procedural reasons, it referred to it as a "major" PBM, raising expectations that it may be listed on the public insurance formularies of the three major PBMs. Previously, the formulary listings of OptumRx, which excluded Yuflyma and Hadlima, were limited to the private insurance sector. PBMs often operate separate formularies for public and private insurance. Within OptumRx, the ratio of public to private insurance is known to be approximately 45 to 55.

Celltrion Healthcare also stated, "We are currently negotiating with multiple PBMs" and added, "We will continue to expand discussions with channels that align with our company strategy and do our best to list Yuflyma in insurance markets covering 40% of the U.S. population within this year."

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