Samsung Bioepis’ Hadlima (biosimilar, adalimumab) Receives FDA’s Approval for Autoimmune Diseases

Samsung Bioepis' Hadlima (biosimilar, adalimumab) Receives FDA’s Approval for Autoimmune Diseases

Shots:

  • The FDA’s approval is based on P-III clinical study assessing Hadlima vs reference product, Humira (adalimumab) in 544 patients in a ratio (1:1) with moderate to severe rheumatoid arthritis despite methotrexate therapy
  • The P-III clinical study resulted in biosimilarity data of Hadlima to the reference product Humira, i.e, @24 wks. ACR20 (72.4% vs 72.2%). Hadlima is Samsung Bioepis’ third anti-TNF biosimilar which has received approval in the US
  • Hadlima (adalimumab-bwwd) is a tumor necrosis factor (TNF) blocker, developed by Samsung Bioepis and will be commercialized by Merck in the US with its expected launch after Jun 30, 2019 in accordance with a licensing agreement signed with AbbVie

Click here to read full press release/ article | Ref: Businesswire | Image: Pharma Boardroom