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Biosimilar Hadlima (Adalimumab-bwwd) Approved for Treatment of Rheumatic Diseases

Web Exclusives - FDA Approvals, News & Updates

On July 24, 2019, the US Food and Drug Administration approved adalimumab-bwwd (Hadlima; Samsung Bioepis), a biosimilar to adalimumab (Humira; AbbVie) for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.

This approval was based on results from the 52-week, double-blind phase 3 clinical trial of 544 patients with moderate-to-severe rheumatoid arthritis who did not respond to previous methotrexate therapy. Patients were randomized to receive either adalimumab-bwwd or the adalimumab reference product.

Results showed that, at week 24, the American College of Rheumatology’s ACR20 response rate was 72.4% for patients treated with adalimumab-bwwd compared with 72.2% for patients treated with the reference product.

After completion of 24 weeks, 254 patients in the adalimumab arm were rerandomized in a 1:1 ratio to continue the reference drug or transition to adalimumab-bwwd, whereas 254 patients in the adalimumab-bwwd arm remained on the same therapy.

The efficacy, safety, and immunogenicity profiles in all 3 treatment groups were comparable up to week 52. In addition, no treatment-emergent adverse events or clinically relevant immunogenicity were reported as a result of switching therapies.

The most common adverse events (>10%) associated with adalimumab-bwwd treatment were infections (eg, upper respiratory, sinusitis), injection-site reactions, headache, and rash.

Adalimumab-bwwd is Samsung Bioepis’ third antitumor-necrosis factor biosimilar approved for marketing in the United States. It is also Samsung Bioepis’ fourth biosimilar approved in the United States, following the approval of infliximab-abda (Renflexis) in April 2017, trastuzumab-dttb (Ontruzant) in January 2019, and etanercept-ykro (Eticovo) in April 2019.

Samsung Bioepis launched adalimumab-bwwd in the European Union in October 2018, following the expiration of AbbVie’s adalimumab patent in the region. In the United States, Merck will commercialize adalimumab-bwwd, which is expected to be available after June 30, 2023, under a licensing agreement with AbbVie.

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Last modified: July 29, 2019
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