First Humira Biosimilar Launches in US

UPDATED February 1, 2023 // Editor's note: This article has been updated with additional comments.

The first biosimilar for Humira, adalimumab-atto (Amjevita), is now available in the United States, according to an announcement today by the manufacturer, Amgen. At least seven other US Food and Drug Administration (FDA)–approved Humira biosimilars are expected to become available later this year.

Amjevita was approved by the FDA in September 2016 for multiple inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. The delayed launch was part of a global settlement with Humira's manufacturer, AbbVie.

Humira (adalimumab) has been available since 2002 and is consistently one of the top-selling drugs in the United States. A single 40-mg Amjevita pen device will be available at two prices: a list price (wholesale acquisition cost) of $1557.59, 55% below the current Humira list price, and a list price of $3288.24, 5% below the current Humira list price, according to Amgen.

"Amgen's goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers," the company said in the January 31 press release.

Patients are less likely to benefit from the more significant discount, said Marta Wosińska, PhD, a healthcare economist at the Brookings Institute in Washington, DC. It's expected that insurance companies will use the higher list price for Amjevita, she said, as this higher price will also likely have higher rebates. Rebates are payments to health insurance payers that are provided by drug manufacturers to promote use of an expensive drug. Some pharmacy benefit managers have already said that they plan to charge patients the same amount for Humira as for its biosimilars, Wosińska said.

“For an existing patient, there's really no incentive for them to switch,” she told Medscape Medical News.

So far, only one insurance company, Kaiser Permanente, has plans to switch patients' prescriptions to biosimilars, according to the health policy podcast Tradeoffs, and the insurer will stop covering Humira by the end of this year.

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Credits:

Lead image: Amgen

Cite this: First Humira Biosimilar Launches in US - Medscape - Jan 31, 2023.

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