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