Ixifi Gets FDA Approval for All Remicade Indications
Clinical data of Ixifi demonstrated a high degree of similarity to Remicade.
Pfizer announced that the Food and Drug Administration (FDA) has approved Ixifi (infliximab-qbtx) as a biosimilar to Remicade (infliximab; Janssen) for all indications of the reference drug. The indications include the treatment of rheumatoid arthritis, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
Ixifi is a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor (TNF). Clinical data of Ixifi demonstrated a high degree of similarity to Remicade. Specifically, the Phase 3, multinational, randomized, double-blind, 2-arm, parallel-group study (REFLECTIONS B537-02) in patients with moderate to severely active rheumatoid arthritis met its primary endpoint of ACR20 response at Week 14; data at Week 30 further supported the initial findings.
Ixifi will be available as a 100mg strength lyophilized powder in 15mL vials for reconstitution. It is intended for intravenous (IV) infusion and is preservative-free.
FDA approves new pfizer biosimilar [press release]. Parsippany, NJ: Pfizer. Published December 13, 2017. Accessed January 5, 2018.