'D-3' Humira Biosimilar Battle... Must Break Through 'PBM' to Survive

Prescription Drug Benefit Management Company PBM
Prescription Possible Only After Drug List Registration

Market 22% Share 'OptumRx'
Domestic Companies Celltrion and Epis Excluded from Registered List
Stock Price Plummeted After News

Other PBMs Still Eligible for Registration
Expecting Success with 'High-Concentration' Development

The U.S. market for biosimilars of the autoimmune disease treatment drug Humira (active ingredient adalimumab), valued at about 24 trillion won, is set to officially open in three days, with pharmacy benefit managers (PBMs) emerging as the key variable that could determine the outcome of the competition.

Unlike Korea, where the government sets drug prices through public insurance, the U.S. mostly operates under a private insurance system where private entities set drug prices. In the U.S. market, PBMs negotiate drug prices and rebate levels with pharmaceutical companies on behalf of insurers and manage the formulary lists of drugs that pharmacies can actually dispense. PBMs often perform similar roles even within public insurance sectors. While not all drugs must go through PBMs, some specialty drugs like Humira are practically impossible to sell in pharmacies unless they are listed on PBM formularies. The success or failure of a product largely depends on how many PBM formularies it is listed on and at what tier.

Currently, the U.S. Humira PBM market is dominated by three major PBMs?CVS Caremark (33%), Express Scripts (24%), and OptumRx under UnitedHealth Group (22%)?which together hold about 80% market share, forming an oligopoly. Successfully getting listed on their formularies can significantly increase market share and allow rapid market capture.

Besides Amgen’s Amjevita, which was first launched in January, more than seven Humira biosimilars are scheduled to enter the market starting next month, including Celltrion’s Yuflyma, Samsung Bioepis’s Hadlima, Sandoz’s Hyrimoz, Alvotech’s Hukyndra, Boehringer Ingelheim’s Cyltezo, Pfizer’s Abrilada, and Coherus’s Yusimry. Biocon’s Hulio and Fresenius Kabi’s Idacio are also planning to launch soon. As the market opening approaches, these biosimilar developers have no choice but to focus intensely on securing PBM formulary listings.

However, on the 23rd (local time), OptumRx, one of the three major PBMs, announced that it would add Amjevita, Cyltezo, and Hyrimoz to its private insurance drug formulary. Since OptumRx had already announced at the end of last year that it would include only three Humira biosimilars on its formulary, other biosimilar developers now face difficulties accessing the private insurance market controlled by OptumRx.

This news caused a sharp drop in the stock prices of related domestic companies. Based on the previous day’s closing prices, Celltrion, which develops and manufactures Yuflyma, saw its stock fall by 8.66%, and Celltrion Healthcare, responsible for overseas sales of Yuflyma, dropped by 8.05%. Samsung BioLogics, the 100% parent company of Samsung Bioepis, which developed Hadlima, also saw its stock decline by 1.58%, likely influenced by this news.

Celltrion Group quickly moved to manage the situation. Celltrion Healthcare posted a notice titled "A Message to Our Shareholders" on its website, stating, "There has been some misunderstanding in the market regarding the PBM formulary listing of Humira biosimilars, and we want to clarify this." They explained, "We are preparing for the launch of Yuflyma in early July and aim to secure formulary listings covering 40% of the total adalimumab market. We are negotiating with PBMs based on the product’s differentiation, superior quality, and profitability considerations."

Since the battle for PBM listings is not over, some analysts believe the market’s concerns are excessive. Kiwoom Securities analyst Heo Hyemin said, "This listing pertains to Optum’s private insurance segment, which accounts for about 55%, while public insurance listings still remain at about 45%. Given the opaque nature of PBM organizations, additional listings are likely, and the duration of listings varies depending on rebate amounts." In other words, only about 12% of the total market is currently closed off, and even that is not completely closed.

The fact that the U.S. Humira market has already been reorganized around the high-concentration formulation (HCF) also increases the possibility of a comeback. Humira is divided into a low-concentration formulation of 50 mg/mL and a high-concentration formulation (HCF) of 100 mg/mL, which reduces the drug dosage by half. As of last year, 85% of adalimumab sold in the U.S. was HCF. While there is still demand for the low-concentration product, preference for HCF is much higher.

This also explains why Amgen’s Amjevita, the first PBM-listed biosimilar, has yet to achieve significant results. Amjevita was developed only in the low-concentration form, and the HCF version is still in clinical trials. Amgen plans to launch the HCF Amjevita next year. According to Samsung Securities, only 1,546 prescriptions of low-concentration Amjevita were made in the U.S. last month, with a market share of just 0.6%. Although this is more than double the 662 prescriptions from the previous month, it has not yet made a major impact.

Meanwhile, among the adalimumab HCF products currently approved in the U.S., only three biosimilars exist besides the original: Hadlima (Samsung Bioepis), Yuflyma (Celltrion), and Hyrimoz (Sandoz). Since two of these, except Hyrimoz, are domestic products, there remains strong hope that domestic companies will succeed in the real competition once it begins.

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