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

 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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