Amjevita, first Humira biosimilar, now available to AS patients in US

New medicine's price may be up to 55% less, developer Amgen says

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by Margarida Maia PhD |

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Amgen’s Amjevita, the first biosimilar to Humira (adalimumab) to receive approval by the U.S. Food and Drug Administration, is now available in the U.S. for the treatment of ankylosing spondylitis (AS) and other diseases.

While the medication was initially approved in 2016, Amjevita is only now reaching the market due to patent protections on AbbVie’s Humira.

While the patent on Humira is valid until 2034, AbbVie entered into agreements with several companies, including Amgen, to allow some biosimilars to enter the market as early as 2023.

“Amjevita is the first U.S. biosimilar to Humira, a medicine used by more than a million patients living with certain serious inflammatory diseases,” Murdo Gordon, Amgen’s executive vice-president of global commercial operations, said in a company press release.

A biosimilar is a medication that’s similar to an existing, approved biological medicine — which is called the reference medicine. It’s designed to have the same properties as the reference medicine, and to have similar safety and effectiveness. But like a generic medicine, it’s often cheaper than the original medication.

Amjevita provides another treatment option for patients and their doctors.

According to Amgen, Amjevita is listed at a discount wholesale acquisition price of either 5% or 55% below Humira’s current price. The company’s goal is to provide broad access to the medicine by offering two options to health insurance plans and pharmacy benefit managers.

“With our track record of developing and manufacturing biologics and decades of experience in inflammation, Amgen is uniquely equipped to supply this biosimilar medicine while reducing costs,” Gordon said.

Adalimumab, the active ingredient in Humira and Amjevita, is an antibody that works by blocking the activity of a protein called tumor necrosis factor (TNF).

This protein is produced by immune cells and is involved in the inflammatory process that occurs in diseases such as AS. By blocking the activity of TNF, adalimumab helps to reduce inflammation and relieve the symptoms of AS and other diseases.

“Biosimilars are extensively studied, FDA-approved treatments that have the potential to reduce costs to the healthcare system,” said Steven Taylor, president and CEO of the Arthritis Foundation.

“Amjevita provides another treatment option for patients and their doctors,” Taylor said.

Available as a citrate-free solution, Amjevita is injected under the skin (subcutaneously) using either a prefilled syringe or autoinjector pen.

The medicine has been used for more than four years outside the U.S., where it’s marketed as Amgevita. As of mid-2022, it has been prescribed to more than 300,000 patients across 60 countries, according to Amgen.