Amgen Launches Amjevita, First Humira Biosimilar on the U.S. Market

The era of Humira (adalimumab) biosimilars in the U.S. is upon us.

Amgen announced this morning that it is selling Amjevita (adalimumab-atto), the first biosimilar to Humira (adalimumab), in the U.S. Perhaps as many as nine other biosimilar’s AbbVie’s blockbuster drug may come on the market this year.

Although the FDA approved Amjevita in September 2016, patent litigation and legal agreements among AbbVie and Amgen and other biosimilar makers have kept the approved biosimilars off the U.S. market till now.

Amgen said in this morning’s announcement that it is pricing its biosimilar at two prices: a wholesale acquisition cost (WAC) price that is 55% below Humira’s list price of about $84,000 per year, which works out to be about $46,200 per year. The company said the other price would be 5% below Humira’s list price, which works out to $79,800 per year.

Some payers may buy at the Amjevita at the higher list price because the true, “net” cost will be lower because of rebates and discounts.

“The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices,” wrote Zachary Brennan of Endpoints News.

Amjevita is citrate-free, low concentration form of adalimumab. Amgen is testing a high concentration version in clinical trials. Amgen has indicated that it will seek “interchangeable” status for Amjevita, which means, depending on state-level pharmacy rules, it could be substituted for brand-name Humira at the pharmacy level.

Humira, an injectable drug used to treat rheumatoid arthritis and a variety of other diseases, is the top-selling drug of all time, with annual sales that are now about $20 billion.

Biosimilars are supposed to create price competition for biologics such as Humira in the same way that generic medications have created price competition for brand-name, small-molecule drugs — generic atorvastatin for Lipitor, for example.

People in the pharmaceutical industry, payers, professional organizations and patient groups have been eyeing 2023 as an important year for biosimilars and the predicate that they will drive down prices. In its recent report on global drug sales, IQVIA projected that the growth in spending on drugs for immunological conditions would slow to 3% to 6% over the next five years because of the Humira biosimilars.

But how soon and at what volume the Humira biosimilars will actually get prescribed will depend on a number of factors, including their placement on the formularies of pharmacy benefit managers.

Formulary Watch®, a news website affiliated with Managed Healthcare Executive®, reported today that CVS Caremark will continue to keep Humira in a preferred position on its formulary and that Amjevita will be placed on a non-preferred brand tier. Beginning Feb. 1, it will cover Amjevita on its commercial template formularies.

“We believe this approach provides coverage for members who choose to access the biosimilar, but provides flexibility to continue to evolve our formulary strategy and minimize member disruption as additional biosimilars launch beginning in July,” a company spokesperson told Formulary Watch®.

A spokesperson from Prime Therapeutics told Formulary Watch® that it is not adding Amjevita at this time and has no further updates.

Express Scripts has indicated that it will add biosimilars to its largest formularies as preferred products to treat inflammatory conditions, but the PBM hasn’t decided yet which of the Humira biosimilars it will add, Formulary Watch® reported. Optum Rx has said it will include Amjevita and two other biosimilars on its Select and Premium formularies, according to the website.