FDA Approves Abrilada, Fifth Biosimilar to Humira

November 18, 2019

Biosimilars Team

The U.S. Food and Drug Administration (FDA) has approved the tumor necrosis factor blocker Abrilada (adalimumab-afzb; Pfizer Inc.), a biosimilar to Humira (adalimumab; AbbVie Inc.). It is the fifth biosimilar to Humira: Amjevita (adalimumab-atto; Amgen, Inc.) was approved in September 2016, Cyltezo (adalimumab-adbm; Boehringer Ingelheim) was approved in August 2017, Hyrimoz (adalimumab-adaz; Sandoz) was approved in October 2018, and Hadlima (adalimumab-bwwd; Samsung Bioepis) was approved in July 2019.

Abrilada is approved for seven indications included in the reference product label:

  • Moderately to severely active rheumatoid arthritis in adults.
  • Active psoriatic arthritis in adults.
  • Active ankylosing spondylitis in adults.
  • Moderately to severely active Crohn’s disease in adults.
  • Moderately to severely active ulcerative colitis in adults.
  • Moderate to severe chronicplaque psoriasis in adults.
  • Moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older.

Detailed information about the approved uses is provided in the full prescribing information. Abrilada is not approved as an interchangeable product.

Pfizer is working to make Abrilada available in the United States as soon as feasible based on the terms of its agreement with AbbVie. Current plans are to launch in 2023.

As with the other adalimumab products, Abrilada contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections that may lead to hospitalization or death. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products. Abrilada must be dispensed with a patient Medication Guide that describes important information about its uses and risks.