The VA Replaces Humira with Hadlima on National Formulary

The U.S. Department of Veterans Affairs (VA) has selected Hadlima (adalimumab-bwwd) to replace Humira on the VA National Formulary. Hadlima, developed by Organon and Samsung Bioepis, is a biosimilar of Humira that launched in the United States in July 2023. It is available in both citrate-free high concentration and citrate-containing low concentration and was one of eight Humira biosimilars that launched at that time.

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. Hadlima’s PushTouch autoinjector was designed with a thin 29G needle, a latex-free needle cover, and a buttonless device with a sure-grip shape and a non-slip surface.

Organon's partner Samsung Bioepis submitted to the FDA in August 2023 an application for Hadlima to be interchangeable with Humira. This application was based on data from a phase 4 study that assessed the pharmacokinetic similarity between two treatment groups: patients with moderate-to-severe plaque psoriasis who switched multiple times between high-concentration formulations of Humira and Hadlima versus patients receiving Humira continuously.

A carton of Hadlima including two pre-filled pens or two pre-filled syringes is available at a list price of $1,038. Organon offers a $0 copay card for commercially insured patients, as well as patient assistance for those who qualify

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 millionn in 2023 compared with $19 million in 2022.

Related: Humira Biosimilar Hadlima Making Coverage Inroads on Formularies

Payers now covering Hadlima include United Healthcare, Prime Therapeutics and associated Blues plans, and some managed Medicare organizations. As of the end of January, Hadlima continued to lead all biosimilars in total prescriptions for the previous eight weeks, a company spokesperson said. The spokesperson said the company expects ongoing changes through 2024 and beyond as payers enable broader access to biosimilars.

Jon Martin

“Our goal steadfastly has been to lower costs for both patients and the healthcare system at large via biosimilars, but we can’t do that alone: we need all the players in between to be invested with us, and that translates into covering – and prioritizing – biosimilars over reference products,” Jon Martin, head, U.S. biosimilars at Organon, told Formulary Watch. “To that end, we have focused our efforts with those that share our goal, such as the VA, to translate use of biosimilars into maximum value.”

The Humira biosimilar market continues to see changes as payers consider their options. Last month, for example, CVS Caremark announced that in April 2024, it will remove Humira from its national commercial template formularies in favor of biosimilars. CVS’ new division Cordavis, which was launched in August 2023, is working directly with pharmaceutical manufacturers to co-produce biosimilar products. CVS Caremark has announced that AbbVie, the manufacturer of Humira, has entered into an agreement to supply Cordavis with a committed volume of co-branded Humira. The Cordavis Humira product will be available in the second quarter of 2024.

Cordavis has also contracted with Sandoz to commercialize and bring to market Hyrimoz, another Humira biosimilar produced by Sandoz, in the first quarter of 2024 under a Cordavis private label.

In a press release, CVS Caremark said Humira will continue to be an option for its customers with Choice and Standard Opt Out commercial formularies. A CVS company spokesperson indicated that CVS Caremark will also include Hadlima and adalimumab-fkjp (the Biocon-produced unbranded Hulio) on select template formularies.