Innovent Biologics Reports Results of IBI303 (biosimilar, adalimumab) in P-III Studies for Ankylosing Spondylitis

 Innovent Biologics Reports Results of IBI303 (biosimilar, adalimumab) in P-III Studies for Ankylosing Spondylitis

Shots:

  • The P-III study involves assessing of IBI303 (SC, 40 mg/0.8 ml, q2w) vs the reference product, Humira (adalimiumab) in 438 patients with ankylosing spondylitis across 20 hospitals in China
  • The P-III study resulted in meeting its 1EPs, @24wks. ASAS20 response rate (75% vs 72%) & 2EPs i.e, ASAS20 @12wks., ASAS40 @24wks; ASAS partial response rates, ASAS5/6 response rate, and BASDAI and were published in The Lancet Rheumatology
  •  IBI303 is a mAb of TNF-alpha having the same amino acid sequence, showing a high degree of biosimilarity data to the reference product, AbbVie’s Humira and has received NMPA’s Priority Review for its NDA

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