FDA Approves the Biosimilar Hadlima (Adalimumab-bwwd)

In late July, the U.S. Food and Drug Administration (FDA) approved Hadlima (adalimumab-bwwd) for treating rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.¹ The treatment is biosimilar to the immunosuppressive treatment Humira (adalimumab).

This approval was based on data from a randomized, double-blind, 52-week phase 3 study in patients (n=544) with moderate to severe RA experiencing symptoms despite methotrexate therapy. Patients were randomized to receive either Hadlima or Humira. At Week 24, the ACR20 response rate was 72% for both agents with a similar safety profile. At Week 24, 254 Humira-treated patients were re-randomized in a 1:1 ratio to continue on Humira or transition to Hadlima. Meanwhile, 254 Hadlima-treated patients continued their treatment.

The efficacy, safety and immunogenicity were similar between all three treatment groups up to Week 52. No treatment emergent issues or clinically relevant immunogenicity issues occurred in patients between the different treatments.

The treatment was previously approved as Imraldi by the European Medicines Agency in June 2016 and as Hadlima by Korea’s Ministry of Food and Drug Safety in September 2017.²

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Samsung Bioepis Co. Ltd. News release: FDA approves Samsung Bioepis’ Hadlima (adalimumab-bwwd). 2019 Jul 24.
2. Generics and Biosimilars Initiative. News: FDA approves adalimumab biosimilar Hadlima. GaBI Online. 2019 Aug 20.