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
Click here to read full press release/ article | Ref: Innovent Biologics | Image: GMP News