Hadlima Approved as Biosimilar for Humira
July 23, 2019 – The U.S. FDA has approved Hadlima™ (adalimumab-bwwd), manufactured by Samsung Bioepis, as a biosimilar for AbbVie’s Humira® (adalimumab). The product is indicated to treat rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD) in adults, ulcerative colitis (UC), and plaque psoriasis (Ps). It is the third biosimilar from Samsung Bioepis to receive FDA approval this year.
In a randomized, double-blind study, 544 patients with moderate to severe rheumatoid arthritis despite treatment with methotrexate received either Hadlima or Humira. By week 24, the Hadlima response rate was 72.4%, compared to 72.2% for Humira. Hadlima also had a comparable safety profile compared to Humira. Half of the patients receiving Humira were then switched to Hadlima for the remainder of the 52-week study. At week 52, Hadlima continued to demonstrate efficacy, safety and immunogenicity profiles comparable to Humira. Recommended dosing varies based on the indication. A black box warning cautions that TNF blockers like Hadlima are associated with risk of serious and potentially fatal infections and malignancies.
Samsung Bioepis plans to launch its product after June 2023, per a licensing agreement with AbbVie. Pricing plans have not been announced.