Amgen’s Avsola (biosimilar, infliximab) Receives the US FDA’s Approval for the Same Indications as Remicade (infliximab)

Amgen’s Avsola (biosimilar, infliximab) Receives the US FDA’s Approval for the Same Indications As Remicade (infliximab)

Shots:

  • 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