FDA approves Samsung Bioepis company Hadlima for treatment of a variety of autoimmune diseases

, south Korea's bio
pharmaceutical(http://company(http://Samsung Bioepis announced that the U.SFood andDrug(http://Authority (
FDA(http://) has approved Hadlima (adalimumab-bwwd, Adamu mono-resistant) for the treatment of a variety of autoimmune diseasesThe drug can be used to treat: rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriasis arthritis (PsA), strong syllanitis (AS), adult Crohn's disease (CD), ulcerative colitis (UC), plaque psoriasisAbout HadlimaHadlima is a biosimilar of(http:// , Aberystwyth's flagship product, Humira, generic name: adalimumab, Adamu mono-resistant 　　Hadlima was developed by Samsung Bioepis and will be commercialized in the United States by partner Mercado Under the license agreement with AbbVie, Hadlima is expected to be available in the U.S after June 30, 2023 　　The study FDA-approved Hadlima based on data from a randomized, double-blind 52-week Phase III study The study enrolled 544 patients with moderate to severe rheumatoid arthritis (RA) who received poor control of methotrexate (MTX) In the study, patients were randomly assigned to Hadlima or Adamu monoantigen reference products (ADL) treatment 　　Data show that in week 24, the ACR20 response rate in the Hadlima treatment group was 72.4% and the ADL group was 72.2% During 24 weeks of treatment, Hadlima's safety was comparable to ADL 　　At week 24, 254 patients receiving ADL were re-grouped at 1:1, continued aDL or transitioned to Hadlima, and 254 patients who received Hadlima continued to receive Hadlima treatment 　　As of week 52, the efficacy, safety and immunogenicity of the three treatment groups remained comparable Patients received 2 drug alternating therapy without treatment-induced problems or clinically related immunogenicity