FDA clears Samsung Bioepis' Hadlima as biosimilar referencing AbbVie's Humira

Samsung Bioepis on Wednesday announced that the FDA approved Hadlima (adalimumab-bwwd), a biosimilar version referencing AbbVie's Humira (adalimumab), for the treatment of adult Crohn’s disease, ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, rheumatoid arthritis and ulcerative colitis. The drugmaker noted that the therapy, which will be marketed by Merck & Co. in the US, will be launched in the country after June 30, 2023 under the terms of a patent infringement lawsuit settlement with AbbVie. 

Approval of the drug was backed by a 52-week Phase III study of 544 patients with moderate-to-severe rheumatoid arthritis despite methotrexate therapy. According to Samsung Bioepis, after 24 weeks of treatment, Hadlima had a response rate of 72.4%, versus 72.2% for Humira, while the drugs had similar safety profiles. Further, at week 24, 254 patients receiving adalimumab reference product (ADL) were re-randomised to continue on ADL or transition to Hadlima, while 254 patients receiving Hadlima continued to receive the therapy. The drugmaker noted that "up to week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups". 

Hee Kyung Kim, head of regulatory affairs at Samsung Bioepis, remarked "with the approval of Hadlima, we are proud to have three anti-TNF biosimilars approved in the US." The drugmaker previously gained clearance of Renflexis (infliximab-abda) in the US as a biosimilar referencing Johnson & Johnson's Remicade (infliximab) in 2017, while Ontruzant (trastuzumab-dttb), a biosimilar version of Roche's Herceptin (trastuzumab), was approved by the FDA earlier this year. 

Meanwhile, AbbVie has separately reached settlements of patent litigation regarding Humira with several other drugmakers, including Amgen, Boehringer Ingelheim, Fresenius Kabi, Mylan, Novartis' Sandoz unit and Pfizer. Sales of Humira fell by 5.6% in the first quarter to $4.45 billion due to biosimilar competition outside the US. 

To read more Top Story articles, click here.