Samsung Bioepis’ BLA for SB5 Adalimumab Biosimilar Accepted for Review by the US FDA

Samsung Bioepis’ BLA for SB5 Adalimumab Biosimilar Accepted for Review by the US FDA

Shots:

  • The BLA (Biologics License Application) has been accepted under the 351(k) pathway for SB5, which was filed by Samsung Bioepis in Jul 2018. Samsung Bioepis’ SB5 is already approved by EU, KFDA, Australia’s TGA and Health Canada
  • Acceptance is based on P-III study on 544 patients with moderate to severe rheumatoid arthritis even with MTX therapy, randomized with SB5 vs Humira. Study results: (N=544) ACR20@24wk (72.4% vs 72.2%), after 24wk, 50% population was re-randomized 1:1 ratio with SB5/Humira and 50% remained on SB5. At 52wk, the efficacy, safety and immunogenicity profiles were comparable b/w groups
  • The SB5’s safety profile comparable to Humira up to Week 24. No treatment based issues or clinical immunogenicity advanced by switching subjects. Adalimumab is an injectable, biologic medication inhibits Tumour Necrosis Factor (TNF), which is indicated for autoimmune diseases such as rheumatoid arthritis, plaque psoriasis, crohn’s disease and ulcerative colitis

Click here to read full press release/ article | Ref: Samsung Bioepis | Image: Businesskorea