FDA Approves Humira Biosimilar

The FDA recently approved Amjevita (adalimumab-atto), which is a biosimilar to AbbVie’s popular anti-inflammatory drug, Humira (adalimumab). This is the fourth biosimilar that has received FDA-approval thus far.

Biosimilars are biologic products that receive approval based on showing the new product is highly similar to a biological product that already has received FDA approval.

According to a press release from the FDA, the biosimilar Amjevita has been approved for the following indications in adults:

• moderately-to-severely active rheumatoid arthritis
• active psoriatic arthritis
• active ankylosing spondylitis
• moderately-to-severely active Crohn’s disease
• moderately-to-severely active ulcerative colitis
• moderate-to-severe plaque psoriasis

The drug also received approval for moderately-to-severely active polyarticular juvenile idiopathic arthritis in children as young as 4-years-old.

The recent approval was based on a review of data that showed structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and efficacy data that shows Amjevita is a biosimilar to Humira, according to the FDA.

However, the FDA warns that Amjevita is not an interchangeable product for Humira. Serious adverse effects can result from using the drug, including infections and malignancies. Infections and injection site reactions have been reported as the most common expected adverse reactions.

A Boxed Warning has been issued for Amjevita that informs patients and healthcare professionals about an increased risk of serious infections that could result in hospitalization, or even death. The warning also indicates that lymphoma and other cancers have been reported in children and adolescent patients receiving tumor necrosis factor blockers such as adalimumab, the FDA wrote.

“This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and 1 that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

However, recent approval may not indicate that the drug will be on the market soon.

The manufacturer of Humira, AbbVie, went to great lengths to ensure that the drug, even if it received FDA approval, would be kept off the market, likely due to a large portion of their revenue being generated from the drug. AbbVie employed delay tactics by filing a lawsuit that alleges Amgen’s biosimilar, Amjevita, infringes on multiple, valid patents.

The company alleges that Amgen is infringing on 61 Humira patents, but they are only including 10 in the lawsuit. Unfortunately for Amgen, despite approval, this lawsuit may delay the biosimilar from entering the market.