First Humira Biosimilar, Amjevita, Launches in the United States

Despite being approved in 2016, the first adalimumab (Humira) biosimilar, Amjevita from Amgen, has finally launched in the United States. All of the adalimumab biosimilars had reached settlement agreements with AbbVie, the maker of the reference product, that kept the biosimilars off the US market until 2023.

Amjevita is the first adalimumab biosimilar to launch in the United States.

Amgen’s deal with AbbVie gives it 6 months on the market before any other adalimumab biosimilars could launch. While adalimumab biosimilars are just now launching in the United States, there have been options available in Europe and elsewhere for years.

According to Amgen, there will be 2 tiers of pricing for Amjevita. One pricing will be a 5% discount to the reference product’s list price, while the other pricing will be a 55% discount. The 5% discount will be available to payers after taking into account rebating and discounting practices by pharmacy benefit managers. The larger discount will be available when insurers do not take advantage of those discounts and rebates.

“This is a watershed year for biosimilars in the United States,” Julianna M. Reed, executive director of the Biosimilars Forum, said in a statement. “This year, at least 7 FDA-approved Humira biosimilars will launch and have the opportunity to create a more competitive market, which can drastically reduce prescription drug costs.”

Adalimumab is approved to treat a variety of diseases: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn disease, and ulcerative colitis.

In 2021, the reference product generated $20.7 billion in revenue worldwide, and in the over 20 years since it launched, Humira has brought in $200 billion in total sales.

There will be at least 7 other adalimumab biosimilars to launch in the United States this year. After Amjevita’s 6 months of exclusivity, 6 others—Idacio, Cyltezo, Abrilada, Yusimry, Hadlima, and Hulio—are expected to launch in July, and Hyrimoz from Sandoz/Novartis is anticipated to launch in September.

Cyltezo is, as of now, the only FDA-approved interchangeable biosimilar, which may give it an advantage despite launching later in the year. The interchangeability designation means pharmacists, based on state laws, could make automatic biosimilar substitutions without first consulting with the prescribing physician. Biosimilars with the designation are not any better than those without.

However, Cyltezo might not be the only interchangeable adalimumab biosimilar. The FDA is reviewing interchangeability applications for Abrilada, Pfizer’s already approved product, and AVT02, Alvotech’s biosimilar under review with the agency. The FDA is expected to make a decision on AVT02 by April 13.

As these adalimumab biosimilars come to market, their cost-saving potential will largely be determined by payers and physicians to drive uptake and divert patients away from the more expensive reference product.

Factors that may be considered when prescribing adalimumab include whether the product is a high-concentration and/or citrate-free version. The high-concentration formulation means patients have to inject a smaller volume, and the citrate-free formulation causes less injection-site pain. The citrate-free/high-concentration formulation of the reference product has the most market share currently.

Potential savings are another major factor. A study from researchers at the RAND Corporation and the HHS Office of the Assistant Secretary for Planning and Evaluation that was published in the July 2022 issue of The American Journal of Managed Care^® detailed the projected savings for all biosimilars between 2021 and 2025, which totaled $38.4 billion. From 2023 to 2025, adalimumab accounted for half of the savings ($19.5 billion).

“The cost-savings of biosimilars can only be realized if all biosimilars—especially biosimilars for Humira—are fully available and accessible to the patients who need them,” said the Biosimilar Forum’s Reed. “Biosimilars have the potential to save billions of dollars in US health care spending, if—and only if—they have equitable access to formularies, allowing free-market competition to lower prescription drug costs.”