USA — Amgen is set to launch a biosimilar to the widely prescribed Humira, giving physicians and people with conditions like arthritis, psoriasis, and Crohn’s disease a lower-cost option to a treatment now priced at nearly US$90,000 a year.

Amjevita, the new drug, will be sold at a list price ranging from US$1,558 to US$3,288 for a 40 milligram, two-week supply of the injectable drug, according to Amgen, representing discounts of 5% to 55% off the list price of Humira.

Amgen officials said the company wanted to provide broad access for patients by offering two pricing options to health plans and pharmacy benefit managers.

Drug manufacturers pay rebates to insurers and pharmacy benefit managers, which negotiate with drug manufacturers on behalf of insurers.

The amount consumers pay will be determined by their health insurance plan’s pharmacy benefits.

Amjevita is the first of more than a half-dozen biosimilars expected to hit the market this year, competing with AbbVie’s Humira, which has a two-decade exclusivity window and generated more than US$20 billion in sales last year, with an additional US$15.7 billion in the first nine months of 2022.

The majority of those sales are in the United States, following the entry of biosimilar competitors in Europe four years ago,

Amgen’s drug, Amjevita, is the first of nine Humira lookalike versions set to launch this year, helping to end Humira’s reign as one of the pharmaceutical industry’s most profitable products.

Drug manufacturers Organon, Boehringer Ingelheim, Coherus, Mylan, Sandoz, and Pfizer will launch biosimilars this year.

Several pharmacy benefit managers said they plan to include biosimilars on their formularies, the list of drugs a consumer can access through their insurance plan.

The arrival of Humira biosimilars in the United States may have ramifications beyond AbbVie, Amgen, and its competitors.

Their impact may be felt by other drugmakers who market products for the diseases treated by Humira, and their success or failure will be the latest test of biosimilars’ promise to reduce healthcare spending.

Unlike small molecule pills or tablets created through a chemical process, biologic drugs such as Humira are produced in living systems such as cell lines, making them more difficult to characterize and replicate.

Until the passage of federal law in 2010, there was no regulatory pathway in the United States for the approval of a “generic” biologic. It took another five years after that law for the FDA to approve the first biosimilar, Novartis’ Zarxio.

However, because of the relatively small number of competitors and insurer contracting practices, many of the first biosimilars approved in the United States were slow to gain traction.

While this is changing, Humira is regarded as the most significant opportunity to date, owing to its high sales and broad range of approved indications.

It faces far more biosimilar competitors than other biologic drugs that have lost patent protection in recent years, and the market may evolve differently as a result.

Moreover, one of the biosimilars set to be released this year is an “interchangeable” version of Humira that pharmacists will be able to directly substitute for the branded version.

Other biosimilars, while considered equivalent to branded versions, must be prescribed by a doctor.

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