First Humira Biosimilar Launches in the United States

Amgen has announced the launch adalimumab-atto (Amjevita) in the United States, marking the first biosimilar for the reference blockbuster drug Humira to become commercially available.

Adalimumab biosimilars are monoclonal antibodies that act as tumor necrosis factor blockers.

Amjevita is approved for all indications of reference Humira except for hidradenitis suppurativa.

Amjevita is approved for the treatment of rheumatoid arthritis in adults; polyarticular juvenile idiopathic arthritis in children 2 years of age and older; psoriatic arthritis in adults; ankylosing spondylitis in adults; Crohn disease in adults and children 6 years of age and older; ulcerative colitis in adults and children 5 years of age and older; and chronic plaque psoriasis in adults.

"With today's announcement, Amjevita is the first US biosimilar to Humira, a medicine used by more than a million patients living with certain serious inflammatory diseases," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen, in a press release.

Amjevita is the first of several adalimumab biosimilars anticipated to launch in 2023 and is expected to be the only adalimumab biosimilar available until July 2023. Eight other Humira biosimilars have been approved by the FDA, with 2 other biosimilars currently under review.

"Biosimilars are extensively studied, FDA-approved treatments that have the potential to reduce costs to the healthcare system," said Steven Taylor, president and chief executive officer at the Arthritis Foundation, in a press release. "Amjevita provides another treatment option for patients and their doctors."

Amjevita (40 mg) is available at a wholesale acquisition cost that is 55% less than the current Humira list price. The biosimilar will also be available at a list price 5% less than the current Humira list price. Amjevita will be offered in a prefilled syringe and an auto-injector pen.

The anti-TNF-α monoclonal antibody’s active ingredient has the same amino acid sequence as Humira. Outside of the United States, Amjevita has been prescribed to more than 300,000 patients in more than 60 countries, according to Amgen.

In December, the FDA approved Fresenius Kabi’s Humira biosimilar adalimumab-aacf (Idacio) for the treatment of several chronic dermatologic conditions.

The biosimilar is indicated for chronic conditions such as rheumatoid arthritis, plaque psoriasis, ulcerative colitis, psoriatic arthritis, hidradenitis suppurativa, and juvenile idiopathic arthritis. In July 2023, the biosimilar will be available in the United States in a low-concentration formulation, in prefilled syringes or prefilled autoinjection pens.

Adalimumab biosimilars are currently available in at least 37 countries worldwide.

In 2017, AbbVie announced a global resolution of intellectual property-related litigation with Amgen over the biosimilar for Humira. Under the settlement, AbbVie granted Amgen a non-exclusive license to adalimumab beginning on January 31, 2023 in the United States and on October 16, 2018, in several other countries.

The agreement requires Amgen to pay royalties to AbbVie for sales of the biosimilar.

Reference

Amjevita™ (Adalimumab-Atto), First Biosimilar To Humira®, Now Available in the United States. Amgen. News release. January 31, 2023. https://www.amgen.com/newsroom/press-releases/2023/01/amjevita-adalimumabatto-first-biosimilar-to-humira-now-available-in-the-united-states