FDA Approves Hadlima, Fourth Biosimilar to Humira

July 24, 2019

Biosimilars Team

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

Hadlima 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 plaque 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. Hadlima is not approved as an interchangeable product.

Hadlima will be commercialized in the United States by Merck. It is expected to launch after June 30, 2023, in accordance with a licensing agreement signed with AbbVie Inc.

As with the other adalimumab products, Hadlima 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. Hadlima must be dispensed with a patient Medication Guide that describes important information about its uses and risks.