- The approval is based on a study assessing Avsola (infliximab-axxq) vs Remicade at a dose of 3 mg/kg administered as an infusion on day 1, at wks. 2 and 6, and q8w thereafter in 558 patients in a ratio (1:1) with moderate-to-severe RA
- The study demonstrated similar safety and immunogenicity in patients prior treated with Remicade with 1EP as ACR20 @22wks. and 2EPs as change in DAS28-CRP, RD of ACR20, ACR50 and ACR70 @ 2, 6, 14, 22, 30, 34, 38, 46 and 50wks.
- Avsola is a biosimilar referencing J&J’s Remicade and has received approval for all approved indications of Remicade which includes mod. to sev. RA, CD, UC in the adult & children, chronic severe PsO, PsA and AS, marking the fourth FDA approval from Amgen’s biosimilars portfolio
Click here to read full press release/ article | Ref: Amgen | Image: Bisnow