Humira Biosimilars Have a Slow Uptake, Finds Samsung Bioepis Report

Biosimilars of the blockbuster arthritis drug Humira (adalimumab) have reached a market share of 4% as of February 2024, up from 2% in the last quarter of 2023, according to the latest Samsung Bioepis Quarterly Biosimilar Market Report.

Of these, the Humira biosimilar, Hadlima had the highest market share, 1.4%. Hadlima is offered with a low wholesale acquisition cost of 85% off Humira’s list price of $6,922 in 2023. Hadlima, developed by Organon and Samsung Bioepis, launched in the United States in July 2023. It is available in both citrate-free high concentration and citrate-containing low concentration.

Hadlima is a tumor necrosis factor (TNF) blocker indicated for appropriate patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. A carton of Hadlima including two pre-filled pens or two pre-filled syringes is available at a list price of $1,038. For the full year 2023, Hadlima generated $17 million in revenue, according to Organon’s recent earnings report to the SEC. Hadlima’s total worldwide revenue was $44 million in 2023 compared with $19 million in 2022.

The Samsung Bioepis report suggests that on average, biosimilars gain 53% of market share within three years of launch. Therapeutics in oncology, ophthalmology and the pegfilgrastim have the fastest uptake, reaching 75% market share in three years. Among the slowest uptake are the immunology, filgrastim, epoetin alfa and insulin glargine products, reaching 23% market share by year three.

As of April 2024, the FDA has approved 48 biosimilars across 15 biological molecules. Of these approvals, 38 biosimilars have launched in the U.S. market. Across the biosimilars that are on the market, the average sales price has declined by 41% three years post launch. The average sales prices in the price the wholesaler charges a pharmacy.

Related: The VA Replaces Humira with Hadlima on National Formulary

The U.S. Department of Veterans Affairs (VA) selected Hadlima to replace Humira on the VA National Formulary in February, making it the most recent payer to cover the biosimilar. Payers now covering Hadlima include United Healthcare, Prime Therapeutics and associated Blues plans, and some managed Medicare organizations.

The Humira biosimilars have faced more barriers to adoption related to brand contracting and PBM controls, according to an analysis by the Biosimilars Council of IQVIA data.

The uptake of the Humira biosimilars has been driving by small payers not affiliated with the larger PBMs. The larger PBMs prefer Humira with its rebates and fees based on the higher list. Those that do provide coverage with the biosimilars include them on parity with Humira.

Formulary exclusions are one way for PBMs to gain negotiating leverage with manufacturers, Adam J. Fein, Ph.D., said recently in an analysis of Humira biosimilar coverage. This, he said, leads manufacturers to offer larger rebates to avoid exclusion form formularies.

Payers also are continuing to adopt new strategies. For example, CVS Caremark said that it is removing Humira from its national commercial template formularies. Instead, it will favor biosimilars, especially those from CVS’ new division Cordavis. Cordavis launched in August 2023 to work directly pharmaceutical manufacturers to co-produce biosimilar products. The first product to come from this will be a cobranded product of Humira. Cordavis has an agreement with AbbVie, the manufacturer of Humira, to supply it with a with a adalimumab product. The Cordavis Humira product will be available in the second quarter of 2024.

The authors of the Samsung Bioepis report also looked at the impact of the Inflation Reduction Act on the biosimilars market. On the positive side, plans may switch to biosimilars in some categories as they more tightly manage the Part B benefit, and that biosimilars may offer greater cost savings.

On the other hand, Medicare’s drug price negotiation program will likely impose pressure on some drugs and their competitors, making step therapy with biosimilars less attractive, the report suggests. Additionally, caps on Part D cost sharing could reduce members’ financial incentive for switching to a biosimilar.

“We are watching how the IRA develops with great interest, especially how it may impact the market competition for products which have soon-to-arrive biosimilars in the next few years,” Gillian Woollett, VP and head of regulatory strategy and policy at Samsung Bioepis, told Formulary Watch. “It is likely that the IRA will impact drug development and innovation over the long-term too, but that may take a little longer to ascertain. Biosimilars can and do save Americans millions to billions of dollars. However, we need to have a reliable system that allows biosimilars to play that role more fully if they are to realize their potential. This means legislation that facilitates market competition and allows biosimilars to compete fairly through a level playing field.”