FDA Approves Hadlima (Adalimumab-bwwd) Biosimilar

July 23, 2019

TNF blocker biosimilar to Humira (adalimumab, Abbvie).

The FDA has approved Hadlima (adalimumab-bwwd, Samsung Bioepis), a tumor necrosis factor (TNF) blocker biosimilar to Humira (adalimumab, Abbvie) for various conditions. 

Indications for the biosimilar, like the reference product, include:

  • Rheumatoid arthritis (RA)

  • Juvenile idiopathic arthritis (JIA)

  • Psoriatic arthritis (PsA)

  • Ankylosing Spondylitis (AS)

  • Adult Crohn’s Disease (CD)

  • Ulcerative Colitis (UC)

  • Plaque Psoriasis (Ps)

See full prescribing information for complete indication information.

Approval is based upon the results of a randomized double-blind 52-week Phase III study that included 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy. Groups were randomized to recieve either Hadlima or the adalimumab reference product (ADL). At week 24, ACR20 response rate was 72.4% in the group that recieved Hadlima, compared to 72.2% in the ADL group. According to a release, safety and immunogencity profiles recorded at week 52 remained compareable between all treatment groups and no emergent issues or clinically relevant immunogenicity precipiateted by alternating subjects between treatements. 

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Boxed warnings for Hadlima include increased risk of serious infections from TB, bacterial sepsis, invasive fungal infections (ie, histoplasmosis), and infections due to other opportunistic pathogens. Some of these infections may lead to hospitalization or death. 

Healthcare providers should discontinue treatment if infection occurs during treatment. Patients should be monitored for TB throughout the course of the treatment, even if results come back negative. 

Hadlima has also been reported to result in malignancies, some fatal, including lymphoma, in children, adolescents, and young adults. Postmarketing cases of hepatosplenic t-cell lymphoma have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers and Hadlima. 

Hadlima is expected to launch in the United State after June 30, 2023.

Full Prescribing Information